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Dorsally displaced distal radius fractures

in the elderly

PhD Thesis

Sondre S. Hassellund

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© Sondre S. Hassellund, 2023

Series of dissertations submitted to the Faculty of Medicine, University of Oslo

ISBN 978-82-348-0136-5

All rights reserved. No part of this publication may be

reproduced or transmitted, in any form or by any means, without permission.

Print production: Graphics Center, University of Oslo.

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Hvad rager det den, som er sikker på sit, at resten af verden

er ude af trit Piet Hein

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Content

Content ... 5

1 Acknowledgments ... 7

2 Abbreviations ... 9

3 List of papers ... 10

4 Synopsis of studies ... 11

5 Norsk sammendrag ... 14

6 Introduction ... 17

6.1 Epidemiology ... 21

6.2 Classification ... 22

6.3 Treatment ... 24

6.3.1 Background ... 24

6.3.2 Non-operative treatment ... 26

6.3.3 Treatment of osteoporosis ... 27

6.3.4 Surgical treatment ... 27

6.3.5 Complications ... 28

6.3.6 Summary surgical options ... 29

6.3.7 Patient preferences ... 30

6.3.8 Norwegian treatment recommendations for distal radius fractures ... 31

6.4 Summary introduction ... 32

7 Aims of the thesis ... 33

8 Patients ... 34

8.1 Paper 1 ... 34

8.2 Paper 2 and 3 ... 34

9 Methods ... 37

9.1 Paper 1 ... 37

9.1.1 Radiological assessment ... 37

9.1.2 Complications ... 38

9.2 Paper 2 ... 38

9.2.1 Treatment ... 38

9.2.2 Outcome measures ... 42

9.2.3 Statistical methods ... 44

9.3 Paper 3 ... 44

9.3.1 Cost utility analysis ... 44

9.3.2 Costs ... 45

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10 Ethics, approvals, conflicts of interest and funding ... 47

11 Main results ... 48

11.1 Paper 1 ... 48

11.2 Paper 2 ... 50

11.3 Paper 3 ... 53

12 Discussion ... 57

12.1 Discussion of methods ... 57

Paper 1 ... 57

Paper 2 ... 57

Paper 3 ... 59

12.2 Discussion of results ... 59

12.3 Closing remarks - the treatment change during the last decades ... 65

13 Conclusions ... 68

14 Suggestions for further research ... 69

15 References ... 71

16 Appendix ... 90

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1 Acknowledgments

The work this thesis is based on was performed at orthopaedic clinic, Oslo University

Hospital, Ullevål between 2015 and 2022. Since I started in 2012 at the Hand and Elbow unit at Oslo University Hospital, Ullevål, both Torstein Husby, John Willksen and Hallgeir Bratberg have been my boss. You have all believed in me and introduced me to your field of interest in the very best way and have been important for my development as a surgeon and as a researcher. This despite your first comments, Torstein, when we started discussing starting an RCT: “I consider this study unethical”. Thanks to the Orthopaedic Clinic, Oslo University Hospital, for keeping focus both on treating patients and the value of orthopaedic research. I am also grateful for financial support from Sophies Minde Foundation.

Many people have been involved in work this PhD is based on, and I am grateful to you all.

Thank you very much, Frede Frihagen, for being my main supervisor after I commenced the PhD-program. Despite being extremely busy, you find time, you have proper answers and questions, and manage to find the balance between pushing and encouraging. At times, I have felt that the project was not worthy to be finished, maybe because I could not find time for everything. And at those times, you made it feel possible and made me feel skilled

(enough), and that was probably just what I needed. Also, I have not felt alone during the project, I have felt that this has been something I have done together with you and the rest of the team. I am especially happy for being a part of your “the day before Christmas Eve”- to do list.

Thank you, Jan Erik Madsen for overlooking my work and for always being forthcoming and positive. I am most thankful for your quick response to all my enquires and for your accurate and encouraging feedbacks.

Also, thank you so much Zina Zolic-Karlsson for introducing me to Health Economics and for believing the project was worth continuing. And Are Hugo Pripp, thanks for your fast

responses, your immediate understanding of statistics and research, and for allowing silly questions and lack of understanding.

I also must thank all the great people I have been working with, in the orthopaedic clinic at Oslo University Hospital, Ullevål and Storgata, Oslo. Doctors, nurses, and mercantile personnel in Storgata have done a great job recruiting, treating, and keeping track of the study patients. A special thanks to Øyvind Karlsen for reminding everyone on the RCT while recruiting and for administrating the recruiting and follow-up during my fellowship in Australia. All the surgeons and residents at the Hand and Elbow Unit during the trial period have been involved in the treatment and follow-up. Their work has been priceless, the project would not have been possible without you. A special thanks goes to the Hand Therapy Unit in Storgata in general and Carina Rosales in particular. You have not only done a major effort to follow up and keep track of the patients after the research protocol. The Hand Therapy Unit have also taken care of the most challenging patients, those with a prolonged rehabilitation and complications, in the very best way.

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Last, but most importantly, thanks to my immediate family. Dear Runhild, you are my love and my closest friend. You and our 4 children, Daniel, Hedda, Oskar and Matilde, mean everything to me. Thanks to all of you for cheering and for accepting my need for time to read and write. You constantly remind me of the most important aspects of life. It is not obviously right to start such a project in combination with raising four children and working full time at the hospital. At times it felt closer to being wrong. I also must admit, it was not actually planned, either. Sometimes, suddenly, you’re just in the middle of something without knowing how you got there – and not knowing how to get away. Finally, I think I know the way out!

Addendum:

Unfortunately, 2 pages of the 3rd article are missing in the Appendix.

The complete article is accessible here:

https://online.boneandjoint.org.uk/doi/full/10.1302/2633-1462.212.BJO-2021-0108.R1

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2 Abbreviations

AAOS American Academy of Orthopaedic Surgeons AUC Area Under the Curve

AO Arbeitsgemeinschaft für Osteosynthesefragen BSSH British Society for Surgery of the Hand

CE-plane Cost-effectiveness plane CI Confidence interval CRP Central reference point

CONSORT Consolidated Standards of Reporting Trials CTS Carpal tunnel syndrome

CTR Carpal tunnel release

CRPP Closed reduction, percutaneous pinning CRPS Complex regional pain syndrome

DASH Disabilities of the Arm, Shoulder and Hand-score DRF Distal radius fractures

EF External fixation

EQ-5D-5L Euro-Qol- 5 Dimensions 5 Levels EPL Extensor pollicis longus

€ Euro

FPL Flexor pollicis longus

ICER Incremental cost-effectiveness ratio KI Konfidensintervall

MCID Minimal clinically important difference NOK Norwegian krone

NTNU Norwegian University of Science and Technology OTA Orthopaedic Trauma Association

QALYs Quality-adjusted life years

Quick-DASH Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Outcome Measure

PRWHE Patient Rated Wrist/Hand Evaluation ROM Range of motion

RCT Randomized controlled trial

SPSS Commercial statistical software platform VLP Volar locking plate

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3 List of papers Paper 1

Closed reduction of dorsally displaced distal radius fractures in the elderly provided improved final radiographic results

Hassellund SS, Oftebro I, Wiliksen JH, Søreide E, Madsen JE, Frihagen F.

Manuscript in review

Paper 2

Cast immobilization is non-inferior to volar locking plates in relation to QuickDASH after one year in patients aged 65 years and older: a randomized controlled trial of displaced distal radius fractures

Hassellund SS, Wiliksen JH, Laane MM, Pripp AH, Rosales CP, Karlsen Ø, Madsen JE, Frihagen F.

Bone Joint J. 2021;103-B(2):247-255

Paper 3

Surgical treatment is not cost-effective compared to nonoperative treatment for displaced distal radius fractures in patients 65 years and over

Hassellund SS, Zolic-Karlsson Z, Wiliksen JH, Husby T, Madsen JE, Frihagen F.

Bone Jt Open 2021; 2-12:1027-1034

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4 Synopsis of studies Introduction

The dorsally displaced distal radius fracture, the Colles fracture, was thoroughly described by Abraham Colles in 1814. He postulated that with correct treatment, the disability after these fractures was negligible. Correct treatment in Colles’ view was to “guard against the carpal end of the radius being drawn backwards” and fix with firm compress and “tin splints formed to the shape of the arm”, ie to stabilize the fracture and to avoid malalignment.

Operative treatment was introduced in the beginning of the 20th century. During the last decades, the treatment has become more invasive in many regions. For displaced fractures the most common treatment has changed from closed reduction and casting to surgery. The most common surgery has changed from percutaneous techniques to open reduction and fixation with a volar locking plate. About half of all distal radius fractures are seen in patients

³65 years. Malalignment after non-operative treatment is usually well tolerated in the elderly, but the shift towards more surgery and more invasive surgery has been the same in this age group. The clinical gain and economic effect of this shift is debated and is the background for this work.

Aims

The aim of the thesis was to investigate the effect of operative and non-operative treatment after a displaced distal radius fracture in patients 65 years and above, both in a clinical and a cost-effectiveness perspective.

Materials and methods

All studies included patients with AO/OTA class A2/3- and C-fractures. In study 1, we identified 290 patients with an initially displaced distal radius fracture, which underwent non-operative treatment with closed reduction and cast immobilization. These patients had complete sets of radiographs pre- and post-reduction and at follow-up after at least 5 weeks. Radiographs were assessed to determine alignment before and after reduction and after the immobilization period was finished.

Study 2 was a randomized controlled trial, and study 3 was a health economic evaluation

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reduction (when needed) and cast immobilization. If the fracture had a secondary

displacement within 20 days, the patients were eligible for randomization. They were (after consent) randomized to continuing non-operative cast immobilization without re-reduction, or to open reduction and fixation with a volar locking plate. 50 patients were included in each study-group, and they were followed for one year.

Study 2 compared functional outcome scores, radiographs, range of motion and grip strength after 3, 6 and 12 months, and was designed as a non-inferiority trial. The chosen main outcome measure was Quick-Dash after one year. The non-inferiority margin was set to a between-group difference of 8 points in Quick-DASH. Secondary outcome measures included PRWHE, EQ-5D-5L, range of motion and grip strength.

Study 3 was a cost effectiveness analysis comparing the difference in QALY between the groups. EQ-5D-5L and the cost of treatment in a health care provider perspective was used to calculate the incremental cost-effectiveness ratio between the two treatment groups.

Results

Study 1 showed that closed reduction improved alignment in almost all patients, but that most of the fractures redisplaced to some degree during immobilization. However, the mean dorsal tilt was 13 degrees better (95% CI 11.1-14.6, p<0.001) at final follow-up compared to initial radiographs. The proportion of patients with intraarticular step >2 mm was reduced from 5% to 3% (p<0.001). The radius shortened during immobilization resulting in an increase in ulnar variance of 0.5 mm (95% CI 0.37-0.70, p<0.001). 201 patients (69%) had improved alignment at follow-up compared to initial radiographs, 118 patients (41%) had acceptable alignment at follow-up based on a pre-defined limit.

In Study 2, 11 men and 89 women were included. The main finding was that non-operative treatment was non-inferior to operation after 6 and 12 months. The median difference in Quick-DASH was 8 after 3 months (p=0.010), and 5 after 6 and 12 months, (p=0.030 and p=0.206, respectively). The PRWHE-score had a similar development with median difference of 19 after 3 months (p=0.064), 9 at 6 months (p=0.020) and 2 at 12 months (p=0.019). The differences in both scores after 12 months were not considered clinically relevant. However, the larger difference at earlier follow-ups was probably because of a faster recovery in the operative group. Range of motion was similar in the two groups, grip strength was 2 kilos higher in the operative group, also considered below a clinically relevant difference.

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Study 3 revealed higher costs (1500 Euro) in the operative group during the first year after injury. The primary surgery was the main contributor to the difference between the groups.

Despite a difference in QALY of 0.05 in favor of the operative group, this could not outweigh the increased costs, the ICER was higher than the stated “willingness to pay”. Hence, non- operative treatment was considered cost-effective.

Conclusion

Initial closed reduction of dorsally displaced distal radius fractures in patients ³65 years improved alignment throughout the immobilization period, and closed reduction and casting is recommended as initial treatment in displaced fractures. Non-operative treatment of dorsally displaced distal radius fractures was non-inferior to operation with a volar plate.

Non-operative treatment was also cost effective and should be considered as the treatment of choice in most cases.

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5 Norsk sammendrag Introduksjon

Den dorsalt disloserte distale radiusfrakturen ble grundig beskrevet av Abraham Colles I 1814 og kalles også Colles` fraktur. Han mente at ved riktig behandling ville

funksjonsnedsettelsen etter disse bruddene være minimal. Riktig behandling i følge Colles var å «forhindre at den metacarpale ende av radius ble dratt bakover» og samtidig

immobilisere med «kompresser og tin-skinner formet etter armen", altså å stabilisere bruddet og forhindre feilstilling.

Operativ behandling ble introdusert ved begynnelsen av det 20. århundret. Gjennom de siste tiårene har vanligste behandling av feilstilte brudd mange steder endret seg fra reposisjon og gipsing til operativ behandling, og vanligste operasjon har endret seg fra perkutane teknikker til åpen reposisjon og platefiksasjon med volar låseplate. Omtrent halvparten av alle distale radiusfrakturer rammer personer i alderen ³65. Feilstilling i bruddet tolereres vanligvis godt i denne aldersgruppen. Endringen mot hyppigere kirurgi og mer invasiv kirurgi har man også sett i denne aldersgruppen. Den kliniske gevinsten og de økonomiske

effektene av denne endringen er debattert og er bakgrunnen for dette arbeidet.

Mål

Målet med avhandlingen var å undersøke effekten av operativ og ikke-operativ behandling av feilstilt håndleddsbrudd hos pasienter fra 65 år og oppover, både i et klinisk og i et kost- nytte-perspektiv.

Materiale og metode

Alle studiene inkluderte pasienter ³65 år med brudd klassifisert som AO/OTA klasse A2/3 og C. I studie 1 fant vi 290 pasienter med distal radiusfraktur som initialt ble behandlet med lukket reposisjon og immobilisering med gips og som hadde tilgjengelige røntgenbilder både før og etter reposisjon og ved oppfølgning etter minimum 5 uker. Røntgenbildene ble

analysert med hensyn på akse og feilstilling, både før og etter reposisjon og etter minimum 5 ukers gipsbehandling.

Studie 2 var en randomisert kontrollert studie og studie 3 en helseøkonomisk analyse av samme materiale. Pasienter ³ 65 år ble initialt behandlet med lukket reposisjon (ved behov) og immobilisering med underarmsgips. Pasientene med brudd som etter initial behandling

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utviklet feilstilling utover gitte radiologiske kriterier innen 20 dager fra skaden var kandidater for inklusjon i studien. Pasientene som kunne inkluderes ut fra inklusjons- og

eksklusjonskriteriene og som samtykket ble randomisert til fortsatt gipsbehandling eller til operasjon med volar låseplate. 50 pasienter ble inkludert i hver gruppe og de ble fulgt i ett år. Studie II sammenliknet funksjonelle resultater, røntgenbilder, bevegelsesutslag og gripestyrke, og ble designet som en non-inferiority-studie. Quick-DASH var hovedutfallsmål, og terskelverdien for «non-inferiority» var en gruppeforskjell på 8 poeng i Quick-DASH mellom gruppen som ble randomisert til operasjon og gruppen som ble behandlet med gips.

Studie 3 var en kost-nytte-analyse som sammenliknet forskjellen i kvalitetsjusterte leveår mellom de to gruppene. EQ-5D-5L og behandlingskostnader (i et helsetjeneste-perspektiv) ble brukt til å beregne kostnadseffektiviteten mellom behandlingsgruppene, kostnad effekt- brøk (ICER).

Resultater

Studie 1 viste at lukket reposisjon bedret stillingen i bruddet hos de fleste pasientene.

Nesten alle mistet noe av denne bedringen i løpet av ukene med gips. Imidlertid var

gjennomsnittlig dorsal vinkling 13 grader (95% KI 11.1-14.6, p<0.001) bedre ved siste kontroll sammenliknet med før reposisjon og færre pasienter hadde en trinndannelse i leddet på over 2 mm. I løpet av immobiliseringstiden ble det en forkortning av radius på 0.5 mm (95%

KI 0.37-0.70, p<0.001) sammenliknet med bildene før reposisjon. 201 pasienter (69%) hadde bedre radiologisk stilling etter immobilisering sammenliknet med initiale bilder og 118 pasienter (41%) hadde akseptabel radiologisk stilling etter gipsperioden.

I Studie 2 ble det inkludert 11 menn og 89 kvinner. Hovedfunnet var at ikke-operativ behandling var ikke-underlegen (non-inferior) sammenliknet med operasjon etter 6 og 12 måneder. Median forskjell i Quick-DASH var 8 etter 3 måneder (p=0.010), 5 etter 6 og 12 måneder (p=0.030 og p=0.206). PRWHE hadde en tilsvarende utvikling med en median forskjell på 19 etter 3 måneder (p=0.064), 9 etter 6 måneder (p=0.020) og 2 etter ett år (p=0.019). Forskjellen i begge disse utfallsmålene ble ikke ansett som klinisk relevant etter 12 måneder, men det at forskjellen var større mellom gruppene tidlig kan tyde på raskere restitusjon i operasjonsgruppen.

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Etter 12 måneder var bevegelsesutslaget tilsvarende i begge grupper, mens

operasjonsgruppen hadde to kilo høyere gripestyrke. Denne differansen ble heller ikke ansett som en klinisk relevant forskjell.

Studie 3 viste at kostnadene var 15000 NOK høyere per pasient i operasjonsgruppen i løpet av første år etter skaden, og at kostnadene knyttet til den primære operasjonen var

hovedforskjellen mellom gruppene. Til tross for en forskjell i QALY på 0.05 i favør operasjonsgruppen var forskjellen i kostandene større og ICER var høyere enn

«betalingsvilligheten» (WTP). Ikke-operativ behandling ble derfor ansett for å være kostnadseffektivt.

Konklusjon

Initial lukket reposisjon etter dorsalt feilstilt håndleddsbrudd hos pasienter over 65 år bedret den radiologiske stillingen og bedringen vedvarte gjennom gipsetiden. Initial lukket

reposisjon og immobilisering med gips anbefales også i denne aldersgruppen. Ikke-operativ behandling av dorsalt feilstilte håndleddsbrudd var ikke dårligere (non-inferior) enn

operasjon med volar låseplate, også hos eldre som klarer seg selv i hverdagen. Ikke-operativ behandling var også kostnadseffektivt og bør ansees som førstevalg ved dorsalt feilstilte håndleddsbrudd i de fleste tilfeller.

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6 Introduction

History – Abraham Colles and introduction to modern medicine The dorsally displaced distal radius fracture (DRF) is

also known as “fractura radii typica” or Colles fracture. The latter relates to Abraham Colles´

(1773-1843) publication from 1814. He was a professor of anatomy and surgery at Royal College of Surgeons in Ireland. He described the distal radius fracture in the Edinburg Medical and Surgical Journal in the text “On the fracture of the carpal extremity of the radius” 1. The paper gave a thorough

description of Colles´ opinion on the injury, clinical examination, best treatment and expected outcome.

He stated that the fracture had been misunderstood and thought to be a wrist dislocation:

“indeed, the carpus and base of the metacarpus appear to be thrown backward so much, as on first

view to excite a suspicion that the carpus has been dislocated forward”.

However, he was convinced the injury was a fracture despite uncommon findings on clinical examination:

“The absence of crepitus, and of the other common symptoms of fracture, together with the swelling which instantly arises in this, as in other injuries of the wrist, render the difficulty of ascertaining the real nature of the case vary considerable […] he [the examining doctor]

attempts to move the broken pieces of the bone in opposite directions; but, although the patient is by this examination subjected to considerable pain, yet, neither crepitus nor a yielding of the bone at the seat of fracture nor any other positive evidence of the existence of such an injury is thereby obtained.”

He continued to argue that despite the lack of what was considered as typical fracture symptoms and signs, the injury may be distinguished clinically from a dislocation.

Figure 1 Prof Abraham Colles. Public domain

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The beginning of the 15th century is considered as the beginning of the early modern time.

The major change in the understanding of diseases and the human body is representing this transition. The theory of the four liquids, humours, and that diseases was caused by

imbalance of these liquids was gradually left after Vesalius published his work on human anatomy in 1543.2

Even though Abraham Colles was a professor in anatomy the paper does not indicate any pathoanatomical study even though anatomical studies were increasing in popularity at the time. The lack of anatomical examination of the fracture might be the reason for the

misplacement of the site of fracture. Colles stated:

“This fracture takes place at about an inch and a half above the carpal extremity of the radius”

This is about twice the actual distance. Even though Colles probably did not dissect any distal radius fractures, he showed thorough knowledge of the wrist anatomy. In his article he described both the dorsal extensor tendon compartments and their close relationship to the bone in the distal part of the radius as well as the anatomy of the distal radio-ulnar joint, and the ligamentous connection between the radius and the ulna. He described that a

ligamentous injury in the DRUJ could be a part of the distal radius fracture:

“The separation of these two bones from each other is facilitated by a previous rupture of their capsular ligament; an event which may readily be occasioned by the violence of the injury.”

Prof. Colles stated that he was not aware of any prior description of this fracture. The first person to suggest that this injury in fact was a fracture is thought to be the French surgeon, Jean Louis Petit (1674-1750) in 1705. It is, however, unclear whether he actually believed that the injury rather was a fracture than a dislocation as was commonly believed at the time.3 Half a decade later, in 1783, Claude Pouteau´s (1725-1775) memoirs were published posthumously. Pouteau, chief surgeon in Lyon, gave a precise description of the posterior displacement of the distal fragment in these fractures. He also described different types of distal radius fractures. Despite Pouteau´s accurate work and opinion, it was not widely accepted, and especially disputed by the famous Pierre-Joseph Desault (1738-1795). 3 The injury was mostly viewed as a dislocation or a fracture dislocation, also called “Desault´s

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dislocation”. Abraham Colles was aware of Desault´s opinion, and stated in his final paragraph:

“I cannot conclude these observations without remarking, that were my opinion to be drawn from those cases only which have occurred to me, I should consider this as by far the most common injury to which the wrist or carpal extremities of the radius and ulna are exposed.

During the last three years, I have not met with a single instance of Desault's dislocation of the inferior end of the radius, while I have had opportunities of seeing a vast number of the fracture of the lower end of this bone.”

This statement imply that Colles believed his work contradicted Desault’s and the common opinion on this injury.

Colles also described how he believed the injury should be treated. He described both closed reduction and immobilization with splints, which has been the mainstay of treatment ever since. Since the mid-1920th century fixation with wires and external fixators became more popular. Later, plate fixation gained territory as the preferred treatment for many 4, but closed reduction and cast stabilization is still a valid treatment option as Colles´s wrote in 1814:

“It is obvious that, in the treatment of this fracture, our attention should be principally directed to guard against the carpal end of the radius being drawn backwards. For this purpose, while assistants hold the limb in a middle state between pronation and supination, let a thick and firm compress be applied transversely on the anterior surface of the limb, at the scat of fracture, taking care that it shall not press on the ulna; let this be bound on firmly with a roller, and then let a tin splint, formed to the shape of the arm, be applied to both its anterior and posterior surfaces. In cases where the end of the ulna has appeared much displaced, I have laid a very narrow wooden splint on the naked side of this bone.”

Whether more modern treatment, i.e., different operative techniques, provides better clinical outcome is still debated - and was also the starting point for this thesis.

Colles also observed the variation in clinical results after a distal radius fracture. He believed that if the injury was mistaken for a dislocation and treated as this after standard

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“By such mistakes the patient is doomed to endure for many months considerable lameness and stiffness of the limb, accompanied by severe pains on attempting to bend the hand and fingers.”

However, he believed that what he considered as proper treatment would provide better and more predictable results:

“The cases treated on this plan have all recovered without the smallest defect or deformity of the limb, in the ordinary time for the cure of fractures.”

During the 19th century, the prerequisite for - and thereby the possibilities of surgical

treatment in general and operative fracture treatment changed dramatically. In the mid-19th century anesthesia with ether and chloroform became important during surgical procedures.

5 At the same time, in 1848, Ignaz Semmelweis (1818-1865) showed difference in the risk of puerperal fever in two different clinics. He concluded that the staff´s (at one of the clinics) attendance in postmortem examinations increased the risk of puerperal fever in that clinic.2 The antiseptic principles gained popularity, especially through the work of Joseph Lister (1827-1912), the most known surgeon in London at the time.6 Before the detection of X-ray imaging in 1895, operative fixation of fractures was uncommon and the equipment available was limited to simple variants of external fixations and metal wires 7. The main fracture treatment was reduction and immobilization, similar to Colles´ description in distal radius fractures and the most common operative treatment was amputation, mostly after open fractures. 7 After William Conrad Röntgen´s (1845-1923) accidental discovery of what he called X-rays November 8th 1895, the first clinical radiograph was published in Lancet only 3 months later. The clinical benefit of visualizing the fractures was obvious, and in

combination with development of plates and intramedullary nails, the possibility of operative fracture treatment was dramatically changed during the first decades of the 20th century. The first known surgical fixation of a distal radius fracture was in 1908 by Albin Lambotte who placed a wire percutaneously through the radial styloid to retain reduction, however, clinical series from percutaneous pin fixation was not published until 1952.

Lambotte also described the first external fixator with screw fixation to bone in 1900.

Anderson (1934) and Hoffman (1938) both designed a system for external traction for different long bone fractures and they both used a bridging technique for the distal radius.

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The basis of modern orthopaedic surgery can be credited to the advent in the late 19th century of these three game-changing factors: anesthesia, antiseptic treatment, and x-rays.

Despite the lack of radiological examination, anatomical dissection and surgical options, Professor Colles described and discussed aspects of these injuries that are still very much debated. The role of reduction and redisplacement, the instability of the distal radio-ulnar joint, the variation of clinical outcome and their relation to differences in treatment are still important factors both in the daily treatment of these fractures and in the ongoing research in the field. Unfortunately, Professor Colles was not correct in his belief that what he

considered as proper treatment would provide consistency in clinical results: “the nature of this injury once ascertained it will be a very easy matter to explain the different phenomena attendant on it, and to point out a method of treatment which will prove completely

successful.”

Still some patients experience unfavorable results, and what is considered as “complete success” might have changed during these 200 years. The number of unfavorable results is the main reason for the vast number of publications on the topic the last decades and main reason for this thesis.

6.1 Epidemiology

In 2019, there were approximately 178 million new fractures globally.8 Compared to 1990 this number represented a minor decrease in incidence, but a marked increase in the

number of fractures of about 1/3, mainly due to the increasing population and aging.8 Distal radius fractures account for approximately 17% of all fractures 9, and is the second most common osteoporotic fracture.10,11 There is a bimodal distribution of DRFs with a minor peak in young men and a major peek in elderly women.9,12 The incidence in Oslo has been reported higher than in other countries13, with a total number of distal radius fractures of 1490 over 12 months in 1998/1999. The reason for the high incidence in Norway, and in Oslo in particular, of osteoporotic fractures is largely unknown.14 The global trend also showed a reduced fracture incidence for hand and wrist fractures.8 This is in coherence with the findings from Solvang et al in Norway.15 They studied the annual incidence of DRFs in their

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about 50 % of the DRFs in adults affected patients 65 years and above. Women in this age group were affected 6-7 times more often than men (Figure 2). 16 Despite a decreased incidence, an increase in number of fractures is expected due to aging of the population.

Figure 2 Distribution of distal radius fractures per age interval and sex. Data from Swedish fracture register. Figure from Rundgren el. al16. 2020. BMC Musculoskeletal Disorders. Springer Nature.

6.2 Classification

Eponyms from the early description and classification of distal radius fractures are still in use and describe different fracture patterns. The Barton fracture is a partial articular fracture where either the volar or the dorsal part of the joint surface of the radius is in continuity with the shaft. The Smith fracture is a complete fracture with a volar displacement of the distal fragment, while the most common fracture, the Colles´ fracture has a dorsal

displacement of the distal fragment. This thesis is concerning the dorsally displaced distal radius fractures.

Numerous classification systems have been introduced for DRFs since the first classification system in 1939 (Nissen-Lie) and many are in use today. 17 The classification systems have usually been based on morphology from radiographs and injury mechanisms. In the

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classification systems, intraarticular involvement, comminution, and displacement have been important elements. However, the inter-observer and intra-observer reliability are only fair to moderate for the classification systems, and they can only to a small extent serve as a guide for treatment in clinical practice. 18,19 The AO/OTA classification system has shown to be the preferred classification system and is currently widely used, even though it has the same problems as the previous classification systems with moderate reliability, ability to guide treatment and inform on prognosis.20

We have used the AO/OTA classification system in this work. 21 (Figure 3) This system divides the fractures into type A, B or C based on fracture patterns with subgroups for each type describing fracture complexity. Type A is extraarticular, type B is partial articular and type C is complete articular. This thesis is concerning the dorsally displaced fractures (Colles fractures) after a low energy trauma in patients 65 years and older, hence the AO/OTA A2 and A3 and C1, C2 and C3 fractures. (Figure 3)

Figure 3 AO-classification. Fractures studied in this thesis in marked in blue squares.Copyright © 2018 by AO Foundation, Switzerland

The AO-OTA classification system is a complex system with intermediate inter-observer agreement for subgroup classification and the subgroups are mostly used for research purposes. 22,23

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6.3 Treatment 6.3.1 Background

The treatment of distal radius fractures has been thoroughly studied for years, and

treatment has changed dramatically over the last century, especially the last 50 years. 4 The research production on distal radius fractures is vast. Since the first publications around year 1800, the publication rate has increased in an exponential fashion. The first high level

evidence, in the form of a randomized trial, was published 30 years ago. The main controversy is the treatment of the displaced fractures.

Malunion and function

Redisplacement after closed reduction is not uncommon, and in an adult population malunion is correlated to impaired function. Several papers have documented the relationship between reduced function and malalignment. Gliatis et al found increased difficulty in activities of daily life with a dorsal tilt>10 degrees. In addition, union with intraarticular step-off gave reduced mobility in young adults. 24 Wilcke et al found better DASH scores with less displacement, both for dorsal and radial angulation (threshold:

15degrees/10 degrees) and ulnar variance (threshold: 2mm). 25 Finsen et al 26 found an association between clinical outcome scores (DASH and PRWHE) and dorsal tilt, radial inclination, ulnar variance, and radial length. Knirk and Jupiter found that intraarticular step of more than 2 mm increased risk of posttraumatic arthritis. 27 Ng and McQueen concluded in a review from 2011 that the chance for good clinical results improved with less than 2 mm intraarticular gap or step, radial length within 2 mm of the normal length and restored carpal alignment. 28 Further, several studies has showed improved function after corrective

osteotomy29-31 indicating that malalignment was the reason for the impaired function.

These studies were done in mixed-age populations.

Prediction of instability

Because of the risk for reduced function in adults with malunion, several attempts have been done to predict malunion based on the assessment of patient factors and primary radiographs. In 1989, Lafontaine et al32 introduced five factors that indicated instability and secondary displacement: dorsal comminution, dorsal angulation>20 degrees, intraarticular fracture, associated fracture of the ulna and age >60. They hypothesized that patients with

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more than 3 of these factors were prone to loss of reduction and they suggested extra radiological surveillance. Nesbitt at al included patients that had at least 3 of the five Lafontaine-criteria. 33 Only fractures with unacceptable alignment after reduction were included. In their study, age was the only factor with statistically significant prediction of secondary displacement, 46% of the patients maintained adequate reduction. Hove at al34 analyzed non-operatively treated DRFs in a mix-age population. They concluded that initial shortening of the radius, initial dorsal angulation and patient age were risk factors for malunion. Mackenney et al found that higher age, more than 5-10 degrees of dorsal tilt, ulnar variance over 0mm and volar or dorsal comminution increased risk of loss of reduction or malunion. 35 Further, Wadsten et al36 and Makhni et al 37 found that dorsal comminution increased risk of malunion.

The American Academy for Orthopaedic Surgeons (AAOS) published treatment guidelines for distal radius fractures in 2009. They recommended operative treatment for fractures still displaced after primary reduction in adults but were unable to recommend for or against surgery for the patient group above 55 years. 38 Based on the studies analyzing the correlation between displacement and function, they recommended the following radiological thresholds for operative treatment (in the adult population):

- radial shortening >3 mm - dorsal tilt >10 degrees - intraarticular step off >2 mm

These thresholds have been used in recent randomized controlled trials. 39-41 Some also add -radial inclination< 15 degrees42-44

The elderly population

Higher age is the most consistent finding and considered the most important factor to predict redisplacement after closed reduction. At the same time, studies from elderly populations conclude that malunion is better tolerated in the elderly. 39,45-48

Surgery and clinical outcome

In 2007/2008 Handoll et al published several Cochrane reviews comparing different

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population.49-52 The main conclusion was that operative treatment (external fixation) might improve radiological results. They were, however, not able to conclude that surgery could improve function. The main problem was the quality of the studies. Previously, most of the displaced fractures were treated non-operatively, but the trend towards increased

frequency of surgery has continued since the beginning of this century despite these Cochrane reviews. At the same time, there has been a shift in surgical technique from percutaneous techniques towards open plate fixation, especially from the volar side. 16,53 This change is not supported by solid evidence of superior function. Even though malunion is better tolerated in the elderly the change in frequency of surgery and invasiveness has been seen also in the elderly population.46,53

The question has been to what extent operative treatment improves the malalignment and, more importantly, to what extent the improved radiological position provides improved function, especially among elderly. Further, the change towards more invasive and technically demanding operations is also a change from cheaper and simpler methods to more complex and expensive ones. 54 The increase in expenses is also a concern, especially because of the high incidence of DRFs and the expected rise due to the aging of the

population.55,56

6.3.2 Non-operative treatment

Non-operative treatment is still the most used treatment method accounting for approximately 75 % of the primary treatment after DRF in adults. 15,57 Nondisplaced fractures are treated non-operatively without controversy. In many countries displaced distal radius fractures undergo closed reduction and casting at the first visit in hospital or emergency department. No reduction method or way of immobilization have showed to be superior in systematic reviews.58,59 Some papers have compared immobilization for 3 and 5 weeks without finding benefits or adverse effects.60,61

At our unit, displaced fractures are closed reduced in hematoma block anesthesia with the manual traction technique62, and a short arm cast is applied. We usually use a circular Plaster of Paris-cast, and the cast is spilt longitudinally to avoid tightness.

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6.3.3 Treatment of osteoporosis

A distal radius fracture may play an important role for the patient’s future health by acting as an indicator for osteoporosis. The life-time risk of a new osteoporotic fracture after a first osteoporotic fracture is doubled and the risk for a new fracture the first year is three to five times higher than in a population without a previous osteoporotic fracture.63,64

Osteoporotic medication increase bone density and has been documented to reduce fracture risk both for vertebral, non-vertebral and hip fractures 65. Especially vertebral and hip fractures are associated with increased morbidity and mortality. A DRF results in less reduction in quality of life compared to other osteoporotic fractures. 66,67 Further, a DRF often presents earlier in life than vertebral and hip fractures. Therefore, a DRF may provide an opportunity to start anti-osteoporotic treatment and thereby reduce the chance for future fractures, morbidity, and mortality. 68 A Fracture Liaison Service (FLS), a coordinated post-fracture program to avoid future fractures, has become popular around the world to translate the potential gain of anti-osteoporotic medication into fewer secondary

osteoporotic fractures. 69,70 Anti-osteoporotic treatment should be included in the follow-up after a distal radius fracture. 68,71

6.3.4 Surgical treatment 6.3.4.1 External fixation (EF)

The first external fixator with screw fixation to bone was described by Lambotte in 1900, however non-operative treatment was the mainstay of treatment for decades. From 1970 until the beginning of the 21st century EF was an important and much used method to treat DRFs. 72,73 The technique is still in use. Traction is applied over the fracture and the fracture is fixed indirectly with an external fixator anchored in bone proximally and distally. This is used for 5-6 weeks and removed in the out-patient clinic.

6.3.4.2 Closed reduction, percutaneous pinning (CRPP)

The technique was increasingly popular from 1960 and is still in use. 74 The technique involves direct fixation across the fracture after closed reduction and immobilization with a cast.75 Pin fixation is also used as a supplement to external fixation.76 Pin site infection is a

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common, but often a minor complication.77 The risk of malunion after pin fixation increases with age.78 The technique is relatively easy and cheap.79

6.3.4.3 Internal fixation

In the 1990s open reduction and application of dorsal plates became popular for the typical radius fracture. The dorsal plate acts as a buttress to avoid dorsal displacement. Dorsal plating is a technically challenging and has been associated with adhesions, tendon ruptures and synovitis. 80,81

Volar plates were at this time analogously used as a volar buttress for volar angulated fractures and volar partially intraarticular fractures (volar Barton, AO/OTA B).

The advantage of both volar and dorsal plates is early active motion.

Volar plating using fixed angle screws became popular in the beginning of the 21st century, first designed and described by Orby.82 The technique gained popularity early and the use has increased during the last two decades. The fixed angle screws distally made it possible for dorsally displaced fractures to be fixed from the volar approach. The advantage of the volar approach includes a better soft tissue envelope than on the dorsal side, leading to less conflict with the tendons. Compared to the other treatment options like CRPP or EF, volar locking plates (VLP) have made reduction and maintenance of reduction until healing more reliable. They also seem to provide a faster return to normal activities and work because they allow early motion. This seem to be the case both in a mixed age and elderly

population. 39,44

6.3.5 Complications

Both non-operative and operative treatment of distal radius fractures involve the risk of complications. Extensor pollicis longus ruptures are seen in undisplaced or minimally displaced fractures and have been reported in 0.3 to 5% of the fractures.83,84 Equally, both volar and dorsal plating are associated with tendon related problems. Historically, dorsal plates have been associated with a high risk of tendon problems, but low-profile plates have reduced the extent of the problem.85 Volar locking plates have also been associated with complications, especially too long screws penetrating the dorsal cortex or volar prominence

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of the distal end of the plate.76,86,87 Both mistakes increase the risk of tendon injury; too long screws might interfere with extensor tendons and prominence of the plate distally might interfere with flexor tendons, especially flexor pollicis longus.

Median nerve symptoms might occur both in operatively and non-operatively treated patients and may be caused both by nerve contusion and the development of acute carpal tunnel syndrome (CTS). The incidence ranges from 2-8% and might be cause both by the injury and the treatment.88 Radial nerve symptoms (superficial branch of the radial nerve) are most often seen as an iatrogenic injury caused by k-wires or from external fixation.88

Complex regional pain syndrome incidence after a DRF has been reported from 1% to 51

%.89 The large variation is probably mainly caused by difference in the definition of CRPS. 89-

91 There are mainly two types of CRPS. Type I is not related to a specific nerve injury, while type II is caused by a nerve injury from the trauma or the surgery including nerve

compression syndrome such as carpal tunnel syndrome.

Infections are mainly related to surgery (and open fractures), and the risk of infection is especially high after percutaneous procedures such as k-wire fixation or external fixation. In a metaanalysis, Margaliot et al found an infection rate of 11% for those treated with external fixation and 1% for those treated with internal fixation. Most of the infections responded to non-operative treatment.92

6.3.6 Summary surgical options

Both non-operative treatment, EF, CRPP, and VLP are treatment options in use for treating elderly patients with displaced dorsal radius fractures. Dorsal plates are more often used for specific fracture patterns. All treatment options have advantages and disadvantages (Table 1).

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Table 1 Comparison of the most common treatment options in elderly patients. CRPS: Complex regional pain syndrome Treatment Invasive Technical

difficulty Complications Early

mobilization Advantages Disadvantages Closed

reduction and cast

No Low-

easy to learn Possibly increase in CRPS (cast tightness) Malunion

No Low costs

No risk for surgical site infection

Increased risk of malunion/deformity

External

fixation Percutaneous Low to Intermediate, easy to learn

Superficial infection Increase in CRPS with over distraction Injury to sensory branch, radial nerve

No Intermediate

costs No metal left after treatment is finished

Less appealing for the patient Need of follow-up after 1-2 weeks EF need to be removed Closed

reduction percutaneous pinning

Percutaneous Low to Intermediate, easy to learn

Superficial infection Injury to sensory branch, radial nerve

No Intermediate

costs No metal left after treatment is finished

Cast

Need of follow-up after 1-2 weeks Wires need to be removed Volar locking

plate Yes High,

learning curve Tendon ruptures Yes Faster recovery Low risk of malunion

High costs Higher risk for reoperations

6.3.7 Patient preferences

Understanding of the patients’ preferences is increasingly acknowledged as a part of the treatment and may affect outcome. Shared decision-making increases the patient’s confidence in the treatment choice. 93

The patients preferred role for the surgeon are differing from patient to patient. Some prefer to be told what the best treatment option is, while others prefer to be an active part in the decision-making after information of the treatment options.94 The preference is influenced by the patient´s previous experiences and expectations to the surgeon.94 To be able to take part in the decision making, the patients are often given information on pros and cons of the different treatment options. 93 Unbiased information on for example

expected function and recovery time may be difficult due to the diverging evidence. Further, the patients seem to weigh the information given differently, leading to different decisions.

A Norwegian pilot study evaluated patient preferences for treatment of a DRF in an adult population. In the first scenario, the patients were informed about non-operative and operative treatment including immobilization time without information on expected functional results. 31 of 50 patients preferred non-operative treatment. Later, the patients were given information on functional results, recovery, and complication risks. 47 of 50

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patients preferred operation. After information about the different operative techniques, 39 preferred VLP, 11 CRPP and none EF.95

The research on patient preference for treatment after a DRF is currently limited. The preferences in the elderly population even more limited. Nasser et al did semi-structured interviews in patients over 60 years after a DRF. They reported that the main concern was to regain full function, and that the majority preferred VLP. 96 However, patients´ preferences need to be examined further.

6.3.8 Norwegian treatment recommendations for distal radius fractures

In 2006 the Norwegian Orthopedic Association appointed a consensus-group focusing on guidelines for treatment of DRFs. The background was a report based on statistics from Norwegian System of Patient Injury Compensation. In the orthopedic field, suboptimal treatment of distal radius fractures proved to be one of the most frequent diagnostic groups qualifying patients for economic compensation. The treatment of DRFs varied significantly, and a more standardized treatment protocol was warranted. 97-99

The consensus group was led by The Norwegian Knowledge Center for Health Services and was represented by leading orthopedic surgeons from the university hospitals in Norway. A vast number of publications were reviewed, and the results were presented in a systematic review based on the GRADE-approach. 100 The results were presented in a report in 2013. 97 and the main findings were:

• the documentation is not sufficient to determine which reduction method is superior

• some documentation supports the use of EF over CRPP.

• the documentation indicates that CRPP provide better function than cast immobilization, but it is not certain which method of CRPP is best

• the use of void bone filler may improve anatomical outcome compared to cast

immobilization. However, the evidence is insufficient to conclude in terms of function and complications

• some documentation supports the effect of rehabilitation measures, but the relative effect of these measures is not documented

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There were controversies in the group concerning interpretations of the available literature, and no consensus was initially achieved.

However, in 2015, Norwegian Orthopaedic Association presented their guidelines for treatment of distal radius fractures in adults based on the work of the consensus group101 . The most important statements were a “strong recommendation” for surgery of unstable fractures in adults, a "weak" recommendation for surgery of unstable fractures in elderly, and a “week recommendation” in favor of VLP compared to CRPP and EF. In sum, beside addressing a more standardized treatment, the guidelines recommended a shift towards more surgery and more invasive procedures. Despite the recommendation, the treatment of patients over 65 has been and is still particularly debated.

6.4 Summary introduction

Prior to the start of our randomized trial we, like many others, had experienced an increase in surgical treatment of DRFs and a shift towards more invasive procedures. The lack of documentation for the increase in surgery, especially in the older age group, was the background for these studies. Planning the trial, we wanted to compare non-operative treatment with volar locking plates which we considered to be the most interesting comparison. We expected this to provide the largest difference in functional results, radiological outcome, immobilization time and treatment costs. We were also inspired by the work of Arora et al39,46 and wanted to see if their results could be reproduced.

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7 Aims of the thesis

The general aim of the thesis was to increase knowledge on non-operative and operative treatment of DRFs in the elderly population, both from a clinical and economical

perspective.

Further, we aimed

• to investigate if initial closed reduction could improve radiological alignment for dorsally displaced distal radius fractures in patients ≥ 65 years in our institution.

• to compare functional and radiological results after operative and non-operative treatment in a randomized study with independently living patients ≥65 years

• to map the occurrence of complications and secondary surgeries after non operative treatment and after surgery with a volar locking plate.

• to compare the costs and quality of life after operative and non-operative treatment after a dorsally displaced fracture in patients ≥ 65 years

• to evaluate whether operation was cost-effective or not.

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8 Patients 8.1 Paper 1

At Oslo University Hospital, covering about 500.000 inhabitants, about 1200 fractures of the distal radius are treated annually. We used our electronical medical record-tool (DIPS) to identify patients 65 years and older who were diagnosed with a distal radius fracture (ICD-10 code S:525) in 2015, 2018 and 2019. Further, the medical records were accessed to

determine if the patient underwent primary closed reduction. Patients with an AO/OTA class A2/3- and C-fractures with available radiographs before and after closed reduction and at least 5 weeks post injury were included.

8.2 Paper 2 and 3

100 patients 65 years and over were included at the Emergency unit at Oslo University hospital from January 2015 to September 2017. All patients were independently living and had suffered a low energy trauma. The displaced fractures were reduced at first visit.

Eligible patients: Inadequate reduction or (re)displacement within 20 days from injury and a dorsally displaced AO/OTA 2R3 A2/3 or C fracture at inclusion with one of the following: 1)

>10 degrees dorsal displacement, 2) >3 mm shortening of the radius, 3) > 2 mm intraarticular step off. (The AAOS-criteria.38)

Exclusion criteria were previous wrist injury, concomitant injury that could affect outcome, open fracture (GA 2 and 3), mental impairment, tourist, and inability to speak a Scandinavian language.

After written consent the patients were randomized to operative treatment with a VLP or non-operative treatment with cast immobilization in a one-to-one ratio and in blocks of eight. A web-based randomization-service from NTNU was used. 50 patients were included to each treatment group, see Table 2 for baseline characteristics and Figure 4 for the enrollment of the patients.

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Table 2 Patient characteristics at enrollment, paper 2 and 3 (Modified from paper 2, Hassellund et al. 41 2021. J Bone Joint.

Bone & Joint Publishing.)

Non-operative group

Operative group

Mean age 73.9 73.4

Women 42 47

Dominant hand injured 18 24

Dominant hand right 45/50 (90%) 47/50 (94%) Right hand affected 19/50 (38%) 23/50 (46%)

AO/OTA A2 2 3

A3 12 9

C1 11 13

C2 18 16

C3 7 9

A: AO/OTA classification 2R3A C: AO/OTA classification 2R3C

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Figure 4 Enrollment of patients, modified from paper 2, Hassellund et al41. 2021. J Bone Joint. Bone & Joint Publishing.

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9 Methods 9.1 Paper 1

9.1.1 Radiological assessment

Radiographs pre- and post-reduction, and at least 5 weeks post injury were evaluated for dorsal tilt, radial inclination, ulnar variance, and intraarticular step.

Ulnar variance was defined as the vertical distance between the mid-point of the ulnar border of the radius (central reference point, CRP 102) and the most distal point of the ulnar head(Figure 5). The radial inclination was measured from the tip of the radial styloid to CRP.

The radiodense transverse line represent either volar or dorsal ulnar rim of the radius, depending on the angulation of the distal fragment (Figure 6). Because the ulnar corner of the radius represents different anatomical landmark depending on the angulation, the CRP represents a more consistent measure point. The radial tilt was measured on lateral

radiographs as the angle between the longitudinal axis of the radius and the line from the volar to the dorsal rim of the radius (joint line, Figure 6). 102

Figure 5 Central reference point (CRP) of the ulnar border, used for measuring radial inclination and ulnar variance to reduce variation caused by excess dorsal or volar angulation of the distal fragment. Reprinted from Hand Clinics, Vol 21(3), RJ Medoff, Essential radiographic evaluation for distal radius fractures, 279-288, 2005, with permission from Elsevier.

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Figure 6 A: Volar and dorsal tilt on PA-view. A: If there is volar tilt on the articular surface, the transverse radiodense line represents the volar rim. B: If there is a dorsal tilt on the articular surface, the transverse radiodense line represent the dorsal rim of the radius. Reprinted from Hand Clinics, Vol 21(3), RJ Medoff, Essential radiographic evaluation for distal radius fractures, 279-288, 2005, with permission from Elsevier.

In study 1, the fractures were classified as “acceptable aligned” if the following radiological criteria were fulfilled:

- radial shortening <3 mm - dorsal tilt <10 degrees - intraarticular step off <2 mm - radial inclination > 15.

(After AAOS 38, modified. 42,43) 9.1.2 Complications

Medical records were used to identify complications, e.g. CRPS and any secondary operations like corrective osteotomy, carpal tunnel release or transposition after EPL- rupture.

9.2 Paper 2 9.2.1 Treatment

After injury, the patients contacted the Emergency ward or a hospital for a medical examination and initial radiographs. Displaced fractures underwent closed reduction with the manual traction technique in hematoma block anaesthesia, and a circular short arm cast

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was applied (Figure 7, Figure 8 and Figure 9). Afterwards, new radiographs were obtained.

The cast was split longitudinally the next day. Then the patients were followed with radiographs, and they were eligible for inclusion when they met the radiological inclusion criteria.

Figure 7 Hematoma block anesthesia. Photo by Børge Olsen. Printed with patient´s permission.

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Figure 8 Closed reduction with the manual traction technique. Longitudinal traction and reduction of the distal fragment Photo by Børge Olsen. Printed with patient´s permission.

Figure 9 Below elbow circular cast. Photo by Børge Olsen. Printed with patient´s permission.

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The patients were included in the RCT after loss of reduction because we wanted to compare the malaligned fractures with properly aligned fractures (after operation).

Operation with a volar locking plate was chosen because we believed that this treatment would provide the best fixation and most reliably maintain the position until healing and allow early active motion.

Operative group:

The patients were operated on average 12 days post-injury (range: 2-20 days, SD 5). A flexor carpi radialis-approach (modified Henry´s) was used. Pronator Quadratus (PQ) was detached L-shaped and retracted. After reduction, the fractures were fixed with a DVR anatomic plate (Zimmer Biomet, Warsaw, Indiana, USA). The PQ was reattached. After haemostasis, wash- out and wound closure a forearm slab was applied for 14 days and removed at the same time as the stiches (Figure 10 and Figure 11)

Figure 10 Surgical approach (modified Henry´s) and fixation with a DVR anatomic plate. Photo: Jahn Kulø. Printed with patient´s permission.

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Figure 11 Same patient as in Figure 10. Radiographs pre- and post-reduction and post-operative. Printed with patient´s permission. Department of Radiology, Oslo University hospital

Non-operative group:

These patients were already in a below elbow cast, and the cast period was continued to a total of 5 weeks of immobilisation. No re-reductions were performed.

9.2.2 Outcome measures

9.2.2.1 Patient rated outcome measures

The abbreviated version of the Disabilities of the Arm, Shoulder and Hand Outcome Measure (Quick-DASH) after 12 months was the primary outcome measure. It is ranging from 0

(excellent outcome) to 100 points (worst possible outcome).103-105 Quick-DASH is a patient- reported form of 11 elements where the patients rate difficulties and interference with daily life on 5-point Likert scales. Minimal clinical important difference (MCID) of Quick-DASH has been reported from 8-19 points.106-108 Quick-DASH has been used in the evaluation of DRF, is validated for this and there is a validated Norwegian version. 76,105,109

The Patient Rated Wrist and Hand Evaluation Score (PRWHE) is ranging from 0-100 points.

Zero is representing the best possible outcome and 100 the worst. It is a 15-item survey designed to measure wrist pain and disability in activities of daily living and has a validated Norwegian version.110,111 Estimated MCIDs for PRWHE vary from 6-14.106,112,113 PRWHE is also validated for distal radius fractures. 114

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Further, the patients scored their “Satisfaction with wrist function” on a numeric rating scale (1-10, 10 best) at each visit. This is to my knowledge not a validated score.

Health-related quality of life (HRQoL)-instruments provide a non-disease specific outcome measure. Health related quality of life was measured by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L).115 It is a questionnaire with five dimensions; mobility, self-care, activities of daily life, pain and anxiety/depression. There are five possible levels of function (no problem to severe problem) for each dimension. This results in a five-digit number that describes the patients’ health state. This number is transformed to an index value ranging from 0, worst possible state, to 1, best possible state of health-related quality of life. The reported minimal clinical important difference (MCID) for EQ-5D-5L varies from 0.03 to 0.54 with an average of 0.18. 116 The EQ VAS is also a part of EQ-5D and shows the patients self-rated health on a visual analogue scale from 0 (worst imaginable health) to 100 (best possible health).

9.2.2.2 Objective outcome measures

At each follow-up, the patients were examined by an unblinded hand therapist. Range of motion (ROM) was graded in both wrists with a manual goniometer, minimal detectable difference is ranged from 12-30 degrees.117 Grip strength was measured with a Jamar dynamometer (Sammons Preston, IL) and was presented both in kg and as percent of uninjured side. A 10% reduction for right hand dominance was performed. 118 MCID of grip strength is likely to be between 5 and 6.5 kg.119

9.2.2.3 Radiological assessment

All radiographs were evaluated by a musculoskeletal radiologist, unaware of clinical outcome. Radiographs were taken of all patients at first contact after injury, at time of randomization, post-surgery for the operative group, 6 weeks after injury or operation, and then after 3 and 12 months. Dorsal tilt, radial tilt and inclination, ulnar variance and

intraarticular step-off were measured.

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