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Aims. The primary aim of this study was to report the radiological outcomes of patients with a dorsally displaced distal radius fracture who were randomized to a moulded cast or surgical fixation with wires following manipulation and closed reduction of their fracture. The secondary aim was to correlate radiological outcomes with patient-reported outcome measures (PROMs) in the year following injury. Methods. Participants were recruited as part of DRAFFT2, a UK multicentre clinical trial. Participants were aged 16 years or over with a dorsally displaced distal radius fracture, and were eligible for the trial if they needed a manipulation of their fracture, as recommended by their treating surgeon. Participants were randomly allocated on a 1:1 ratio to moulded cast or Kirschner wires after manipulation of the fracture in the operating theatre. Standard posteroanterior and lateral radiographs were performed in the radiology department of participating centres at the time of the patient’s initial assessment in the emergency department and six weeks postoperatively. Intraoperative fluoroscopic images taken at the time of fracture reduction were also assessed. Results. Patients treated with surgical fixation with wires had less dorsal angulation of the radius versus those treated in a moulded cast at six weeks after manipulation of the fracture; the mean difference of -4.13° was statistically significant (95% confidence interval 5.82 to -2.45). There was no evidence of a difference in radial shortening. However, there was no correlation between these radiological measurements and PROMs at any timepoint in the 12 months post-injury. Conclusion. For patients with a dorsally displaced distal radius fracture treated with a closed manipulation, surgical fixation with wires leads to less dorsal angulation on radiographs at six weeks compared with patients treated in a moulded plaster cast alone. However, the difference in dorsal angulation was small and did not correlate with patient-reported pain and function. Cite this article: Bone Jt Open 2024;5(2):132–138


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 993 - 999
1 Sep 2023
van Delft EAK van Bruggen SGJ van Stralen KJ Bloemers FW Sosef NL Schep NWL Vermeulen J

Aims. There is no level I evidence dealing with the optimal period of immobilization for patients with a displaced distal radial fracture following closed reduction. A shorter period might lead to a better functional outcome due to less stiffness and pain. The aim of this study was to investigate whether this period could be safely reduced from six to four weeks. Methods. This multicentre randomized controlled trial (RCT) included adult patients with a displaced distal radial fracture, who were randomized to be treated with immobilization in a cast for four or six weeks following closed reduction. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after follow-up at one year. Secondary outcomes were the abbreviated version of the Disability of Arm, Shoulder and Hand (QuickDASH) score after one year, the functional outcome at six weeks, 12 weeks, and six months, range of motion (ROM), the level of pain after removal of the cast, and complications. Results. A total of 100 patients (15 male, 85 female) were randomized, with 49 being treated with four weeks of immobilization in a cast. A total of 93 completed follow-up. The mean PRWE score after one year was 6.9 (SD 8.3) in the four-week group compared with 11.6 (SD 14.3) in the six-week group. However, this difference of -4.7 (95% confidence interval -9.29 to 0.14) was not clinically relevant as the minimal clinically important difference of 11.5 was not reached. There was no significant difference in the ROM, radiological outcome, level of pain, or complications. Conclusion. In adult patients with a displaced and adequately reduced distal radial fracture, immobilization in a cast for four weeks is safe, and the results are similar to those after a period of immobilization of six weeks. Cite this article: Bone Joint J 2023;105-B(9):993–999


Aims. The aim of this study was to compare the clinical effectiveness of Kirschner wire (K-wire) fixation with locking-plate fixation for patients with a dorsally displaced fracture of the distal radius in the five years after injury. Patients and Methods. We report the five-year follow-up of a multicentre, two-arm, parallel-group randomized controlled trial. A total of 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation were recruited from 18 trauma centres in the United Kingdom. Patients were excluded if the surface of the wrist joint was so badly displaced it required open reduction. In all, 448 patients were randomized to receive either K-wire fixation or locking-plate fixation. In the K-wire group, there were 179 female and 38 male patients with a mean age of 59.1 years (19 to 89). In the locking-plate group, there were 194 female and 37 male patients with a mean age of 58.3 years (20 to 89). The primary outcome measure was the patient-rated wrist evaluation (PRWE). Secondary outcomes were health-related quality of life using the EuroQol five-dimension three-level (EQ-5D-3L) assessment, and further surgery related to the index fracture. Results. At 12 months, 402/448 participants (90%) recruited into the main study provided PRWE scores. At year two, 294 participants (66%) provided scores; at year five, 198 participants (44%) provided scores. There was no clinically relevant difference in the PRWE at any point during the five-year follow-up; at five years, the PRWE score was 8.3 (12.5) in the wire group and 11.3 (15.6) in the plate group (95% confidence interval -6.99 to 0.99; p = 0.139). Nor was there a clinically relevant difference in health-related quality of life. Only three participants had further surgery in the five years after their injury (one in the wire group and two in the plate group). Conclusion. This follow-up study continues to show no evidence of a difference in wrist pain, wrist function, or quality of life for patients treated with wires versus locking plates in the five years following a dorsally displaced fracture of the distal radius. Cite this article: Bone Joint J 2019;101-B:978–983


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1263 - 1271
1 Oct 2019
Eisenschenk A Spitzmüller R Güthoff C Obladen A Kim S Henning E Dornberger JE Stengel D

Aims. The aim of this study was to investigate whether clinical and radiological outcomes after intramedullary nailing of displaced fractures of the fifth metacarpal neck using a single thick Kirschner wire (K-wire) are noninferior to those of technically more demanding fixation with two thinner dual wires. Patients and Methods. This was a multicentre, parallel group, randomized controlled noninferiority trial conducted at 12 tertiary trauma centres in Germany. A total of 290 patients with acute displaced fractures of the fifth metacarpal neck were randomized to either intramedullary single-wire (n = 146) or dual-wire fixation (n = 144). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire six months after surgery, with a third of the minimal clinically important difference (MCID) used as the noninferiority threshold. Secondary outcomes were pain, health-related quality of life (EuroQol five-dimensional questionnaire (EQ-5D)), radiological measures, functional deficits, and complications. Results. Overall, 151/290 of patients (52%) completed the six months of follow-up, leaving 83 patients in the single-wire group and 68 patients in the dual-wire group. In the modified intention-to-treat analysis set, mean DASH scores six months after surgery were 3.8 (. sd. 7.0) and 4.4 (. sd. 9.4), respectively. With multiple imputation (n = 288), mean DASH scores were estimated at 6.3 (. sd. 8.7) and 7.0 (. sd. 10.0). Upper (1 - 2α)) confidence limits consistently remained below the noninferiority margin of 3.0 points in the DASH instrument. While there was a statistically nonsignificant trend towards a higher rate of shortening and rotational malalignment in the single wire group, no statistically significant differences were observed across groups in any secondary outcome measure. Conclusion. A single thick K-wire is sufficient for intramedullary fixation of acute displaced subcapital fractures of the fifth metacarpal neck. The less technically demanding single-wire technique produces noninferior clinical and radiological outcomes compared with the dual-wire approach. Cite this article: Bone Joint J 2019;101-B:1263–1271


The Bone & Joint Journal
Vol. 97-B, Issue 8 | Pages 1082 - 1089
1 Aug 2015
Tubeuf S Yu G Achten J Parsons NR Rangan A Lamb SE Costa ML

We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare the relative cost effectiveness of percutaneous Kirschner wire (K-wire) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius.

The cost effectiveness analysis (cost per quality-adjusted life year; QALY) was derived from a multi-centre, two-arm, parallel group, assessor-blind, randomised controlled trial which took place in 18 trauma centres in the United Kingdom. Data from 460 patients were available for analysis, which includes both a National Health Service cost perspective including costs of surgery, implants and healthcare resource use over a 12-month period after surgery, and a societal perspective, which includes the cost of time off work and the need for additional private care.

There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires. At a mean additional cost of £714 (95% confidence interval 588 to 865) per patient, locking-plate fixation presented an incremental cost effectiveness ratio (ICER) of £89 322 per QALY within the first 12 months of treatment. Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires. These were greater than £30 000.

Compared with locking-plate fixation, K-wire fixation is a ‘cost saving’ intervention, with similar health benefits.

Cite this article: Bone Joint J 2015;97-B:1082–9.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 696 - 704
1 Jul 2024
Barvelink B Reijman M Smidt S Miranda Afonso P Verhaar JAN Colaris JW

Aims. It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting. Methods. In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure. Results. The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur. Conclusion. Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups. Cite this article: Bone Joint J 2024;106-B(7):696–704


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1277 - 1283
1 Jul 2021
Hinde S Richardson G Fairhurst C Brealey SD Cook L Rangan A Costa ML Dias JJ

Aims. The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion. Methods. A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis. Results. Our base case analysis found that patients randomized to early surgical fixation had statistically significantly higher mean costs to the NHS of £1,295 more than for the cast immobilization arm (p < 0.001), primarily due to the cost of surgery. They also had a marginally better quality of life, over the period, of 0.0158 QALYs; however, this was not statistically significant (p = 0.379). The mean combined cost per additional QALY was £81,962, well above the accepted threshold for cost-effectiveness used in the UK and internationally. The probability of early surgery being cost-effective in this setting was only 5.6%. Conclusion. Consistent with the clinical findings of SWIFFT, these results indicate that initial cast immobilization of minimally displaced scaphoid fractures, with immediate fixation only offered to patients with nonunion, is the optimal form of treatment, resulting in comparable outcomes with less cost to the healthcare system. Cite this article: Bone Joint J 2021;103-B(7):1277–1283


Bone & Joint Open
Vol. 2, Issue 5 | Pages 338 - 343
21 May 2021
Harvey J Varghese BJ Hahn DM

Aims. Displaced distal radius fractures were investigated at a level 1 major trauma centre during the COVID-19 2020 lockdown due to the implementation of temporary changes in practice. The primary aim was to establish if follow-up at one week in place of the 72-hour British Orthopaedic Association Standards for Trauma & Orthopaedics (BOAST) guidance was safe following manipulation under anaesthetic. A parallel adaptation during lockdown was the non-expectation of Bier’s block. The secondary aim was to compare clinical outcomes with respect to block type. Methods. Overall, 90 patients were assessed in a cross-sectional cohort study using a mixed, retrospective-prospective approach. Consecutive sampling of 30 patients pre-lockdown (P1), 30 during lockdown (P2), and 30 during post-lockdown (P3) was applied. Type of block, operative status, follow-up, and complications were extracted. Primary endpoints were early complications (≤ one week). Secondary endpoints were later complications including malunion, delayed union or osteotomy. Results. In P1, 86.6% of patients were seen between days one to three, 26.7% in P2, and 56.7% in P3. There were no documented complications from days one to three. Operative rate was 35.5%, which did not vary significantly (p= 0.712). Primary endpoints occurred between day four to seven, and included one patient each period treated for plaster cast pain. Secondary endpoints in P1 included delayed union (one patient). During P2, this included malunion (one patient), a pressure sore (one patient) and ulnar cutaneous nerve symptoms (two patients). In P3, malunion was identified in one patient. Mean follow-up was six months (4 to 9) with union rate 96%. Change in block practice varied significantly (p =<0.05). The risk ratio of complications using regional block (Bier’s) over haematoma block was 0.65. Conclusion. Follow-up adaptations during lockdown did not adversely affect patient outcomes. Regional anaesthesia is gold standard for manipulation of displaced distal radial fractures. Cite this article: Bone Jt Open 2021;2(5):338–343


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1257 - 1262
1 Nov 2024
Nowak LL Moktar J Henry P Dejong T McKee MD Schemitsch EH

Aims

We aimed to compare reoperations following distal radial fractures (DRFs) managed with early fixation versus delayed fixation following initial closed reduction (CR).

Methods

We used administrative databases in Ontario, Canada, to identify DRF patients aged 18 years or older from 2003 to 2016. We used procedural and fee codes within 30 days to determine which patients underwent early fixation (≤ seven days) or delayed fixation following CR. We grouped patients in the delayed group by their time to definitive fixation (eight to 14 days, 15 to 21 days, and 22 to 30 days). We used intervention and diagnostic codes to identify reoperations within two years. We used multivariable regression to compare the association between early versus delayed fixation and reoperation for all patients and stratified by age (18 to 60 years and > 60 years).


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1225 - 1233
1 Nov 2022
Png ME Petrou S Achten J Ooms A Lamb SE Hedley H Dias J Costa ML

Aims

The aim of this study was to compare the cost-effectiveness of surgical fixation with Kirschner (K-)wire ersus moulded casting after manipulation of a fracture of the distal radius in an operating theatre setting.

Methods

An economic evaluation was conducted based on data collected from the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) multicentre randomized controlled trial in the UK. Resource use was collected at three, six, and 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from an NHS and personal social services perspective. Sensitivity analyses were conducted to examine the robustness of cost-effectiveness estimates, and decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 312 - 316
17 Apr 2024
Ryan PJ Duckworth AD McEachan JE Jenkins PJ

Aims

The underlying natural history of suspected scaphoid fractures (SSFs) is unclear and assumed poor. There is an urgent requirement to develop the literature around SSFs to quantify the actual prevalence of intervention following SSF. Defining the risk of intervention following SSF may influence the need for widespread surveillance and screening of SSF injuries, and could influence medicolegal actions around missed scaphoid fractures.

Methods

Data on SSF were retrospectively gathered from virtual fracture clinics (VFCs) across a large Scottish Health Board over a four-year period, from 1 January 2018 to 31 December 2021. The Bluespier Electronic Patient Record System identified any surgical procedure being undertaken in relation to a scaphoid injury over the same time period. Isolating patients who underwent surgical intervention for SSF was performed by cross-referencing the unique patient Community Health Index number for patients who underwent these scaphoid procedures with those seen at VFCs for SSF over this four-year period.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 612 - 620
21 Aug 2023
Martin J Johnson NA Shepherd J Dias J

Aims

There is ambiguity surrounding the degree of scaphoid union required to safely allow mobilization following scaphoid waist fracture. Premature mobilization could lead to refracture, but late mobilization may cause stiffness and delay return to normal function. This study aims to explore the risk of refracture at different stages of scaphoid waist fracture union in three common fracture patterns, using a novel finite element method.

Methods

The most common anatomical variant of the scaphoid was modelled from a CT scan of a healthy hand and wrist using 3D Slicer freeware. This model was uploaded into COMSOL Multiphysics software to enable the application of physiological enhancements. Three common waist fracture patterns were produced following the Russe classification. Each fracture had differing stages of healing, ranging from 10% to 90% partial union, with increments of 10% union assessed. A physiological force of 100 N acting on the distal pole was applied, with the risk of refracture assessed using the Von Mises stress.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 262 - 267
1 Mar 2024
de Villeneuve Bargemon J Mari R Mathoulin C Prenaud C Merlini L

Aims

Patients with midcarpal instability are difficult to manage. It is a rare condition, and few studies have reported the outcomes of surgical treatment. No prospective or retrospective study has reported the results of arthroscopic palmar capsuloligamentous suturing. Our aim was to report the results of a prospective study of arthroscopic suture of this ligament complex in patients with midcarpal instability.

Methods

This prospective single-centre study was undertaken between March 2012 and May 2022. The primary outcome was to evaluate the functional outcomes of arthroscopic palmar midcarpal suture. The study included 12 patients, eight male and four female, with a mean age of 27.5 years (19 to 42). They were reviewed at three months, six months, and one year postoperatively.


Bone & Joint Research
Vol. 12, Issue 8 | Pages 486 - 493
4 Aug 2023
Yamanaka Y Tajima T Tsujimura Y Naito T Mano Y Tsukamoto M Zenke Y Sakai A

Aims

Dupuytren’s contracture is characterized by increased fibrosis of the palmar aponeurosis, with eventual replacement of the surrounding fatty tissue with palmar fascial fibromatosis. We hypothesized that adipocytokines produced by adipose tissue in contact with the palmar aponeurosis might promote fibrosis of the palmar aponeurosis.

Methods

We compared the expression of the adipocytokines adiponectin and leptin in the adipose tissue surrounding the palmar aponeurosis of male patients with Dupuytren’s contracture, and of male patients with carpal tunnel syndrome (CTS) as the control group. We also examined the effects of adiponectin on fibrosis-related genes and proteins expressed by fibroblasts in the palmar aponeurosis of patients with Dupuytren’s contracture.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 946 - 952
1 Aug 2022
Wu F Zhang Y Liu B

Aims

This study aims to report the outcomes in the treatment of unstable proximal third scaphoid nonunions with arthroscopic curettage, non-vascularized bone grafting, and percutaneous fixation.

Methods

This was a retrospective analysis of 20 patients. All cases were delayed presentations (n = 15) or failed nonoperatively managed scaphoid fractures (n = 5). Surgery was performed at a mean duration of 27 months (7 to 120) following injury with arthroscopic debridement and arthroscopic iliac crest autograft. Fracture fixation was performed percutaneously with Kirschner (K)-wires in 12 wrists, a headless screw in six, and a combination of a headless screw and single K-wire in two. Clinical outcomes were assessed using grip strength, patient-reported outcome measures, and wrist range of motion (ROM) measurements.


Aims

The aim of this study was to assess and compare active rotation of the forearm in normal subjects after the application of a short-arm cast (SAC) in the semisupination position and a long-arm cast (LAC) in the neutral position. A clinical study was also conducted to compare the functional outcomes of using a SAC in the semisupination position with those of using a LAC in the neutral position in patients who underwent arthroscopic triangular fibrocartilage complex (TFCC) foveal repair.

Methods

A total of 40 healthy right-handed volunteers were recruited. Active pronation and supination of the forearm were measured in each subject using a goniometer. In the retrospective clinical study, 40 patients who underwent arthroscopic foveal repair were included. The wrist was immobilized postoperatively using a SAC in the semisupination position (approximately 45°) in 16 patients and a LAC in 24. Clinical outcomes were assessed using grip strength and patient-reported outcomes. The degree of disability caused by cast immobilization was also evaluated when the cast was removed.


Bone & Joint Open
Vol. 2, Issue 6 | Pages 447 - 453
1 Jun 2021
Dean BJF Little C Riley ND Sellon E Sheehan W Burford J Hormbrey P Costa ML

Aims

To determine the role of early MRI in the management of suspected scaphoid fractures.

Methods

A total of 337 consecutive patients presenting to an emergency department (ED) following wrist trauma over a 12-month period were prospectively included in this service evaluation project. MRI was not required in 62 patients with clear diagnoses, and 17 patients were not managed as per pathway, leaving a total of 258 patients with normal scaphoid series radiographs who were then referred directly from ED for an acute wrist MRI scan. Patient demographics, clinical details, outcomes, and complications were recorded at a minimum of a year following injury.


Aims

To assess the proportion of patients with distal radius fractures (DRFs) who were managed nonoperatively during the COVID-19 pandemic in accordance with the British Orthopaedic Association BOAST COVID-19 guidelines, who would have otherwise been considered for an operative intervention.

Methods

We retrospectively reviewed the radiographs and clinical notes of all patients with DRFs managed nonoperatively, following the publication of the BOAST COVID-19 guidelines on the management of urgent trauma between 26 March and 18 May 2020. Radiological parameters including radial height, radial inclination, intra-articular step-off, and volar tilt from post-reduction or post-application of cast radiographs were measured. The assumption was that if one radiological parameter exceeds the acceptable criteria, the patient would have been considered for an operative intervention in pre-COVID times.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 137 - 143
1 Jan 2020
Dias R Johnson NA Dias JJ

Aims

Carpal malalignment after a distal radial fracture occurs due to loss of volar tilt. Several studies have shown that this has an adverse influence on function. We aimed to investigate the magnitude of dorsal tilt that leads to carpal malalignment, whether reduction of dorsal tilt will correct carpal malalignment, and which measure of carpal malalignment is the most useful.

Methods

Radiographs of patients with a distal radial fracture were prospectively collected and reviewed. Measurements of carpal malalignment were recorded on the initial radiograph, the radiograph following reduction of the fracture, and after a further interval. Linear regression modelling was used to assess the relationship between dorsal tilt and carpal malalignment. Receiver operating characteristic (ROC) analysis was used to identify which values of dorsal tilt led to carpal malalignment.


The Bone & Joint Journal
Vol. 101-B, Issue 8 | Pages 984 - 994
1 Aug 2019
Rua T Malhotra B Vijayanathan S Hunter L Peacock J Shearer J Goh V McCrone P Gidwani S

Aims

The aim of the Scaphoid Magnetic Resonance Imaging in Trauma (SMaRT) trial was to evaluate the clinical and cost implications of using immediate MRI in the acute management of patients with a suspected fracture of the scaphoid with negative radiographs.

Patients and Methods

Patients who presented to the emergency department (ED) with a suspected fracture of the scaphoid and negative radiographs were randomized to a control group, who did not undergo further imaging in the ED, or an intervention group, who had an MRI of the wrist as an additional test during the initial ED attendance. Most participants were male (52% control, 61% intervention), with a mean age of 36.2 years (18 to 73) in the control group and 38.2 years (20 to 71) in the intervention group. The primary outcome was total cost impact at three months post-recruitment. Secondary outcomes included total costs at six months, the assessment of clinical findings, diagnostic accuracy, and the participants’ self-reported level of satisfaction. Differences in cost were estimated using generalized linear models with gamma errors.