BackgroundScaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased, in spite of insufficient evidence of improved outcomes over non-surgical management. We compared the clinical effectiveness of surgical fixation with cast immobilization and early fixation of those that fail to unite, for ≤2 mm displaced scaphoid waist fractures in adults. MethodsThis pragmatic, multicentre, open-label, parallel-group, two-arm randomised clinical trial included adults who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear, bicortical fracture of the scaphoid waist on radiographs. Participants were randomly assigned to early surgical fixation or below-elbow cast immobilization followed by immediate fixation of confirmed non-union. The primary outcome was the Patient Rated Wrist Evaluation (PRWE) total score at 52 weeks post-randomisation. Registration ISRCTN67901257. FindingsOf 439 randomised patients (mean age 33 years, 363 [83%] men), 408 (93%) were included in the primary analyses. There was no difference in PRWE score at 52 weeks (adjusted mean difference -2•1 points, 95% CI -5•8 to 1•6, p=0•27). There were no differences at 52 weeks for the PRWE pain or function subscales. More participants in the surgery group experienced a surgery-related potentially serious complication than in the cast group (n=31, 14% vs n=3, 1%), but fewer had cast-related complications (n=5, 2% vs n=40, 18%). The number experiencing a medical complication (n=4, 2% vs n=5, 2%) was similar in the two groups." InterpretationAdult patients with ≤2 mm displaced scaphoid waist fracture should have initial cast immobilization and suspected non-unions confirmed and immediately fixed. This will help avoid risks of surgery and mostly limit its use to fixing non-union.
We conducted an observational radiographic study to determine the inter- and intra-observer reliability of the AO classification of fractures of the distal radius. Plain posteroanterior and lateral radiographs of 456 patients with an acute fracture of the distal radius were classified by a consultant orthopaedic hand specialist and two specialist trainees, and the k coefficient for the inter- and intra-observer reliability of the type, group and subgroup classification was calculated. Only the type of fracture (A, B or C) was found to provide substantial intra-observer reliability (k type 0.65). The inclusion of 'group' and 'subgroup' into the classification reduced the inter-observer reliability to fair (kgroup 0.29, ksubgroup = 0.28) and the intra-observer reliability to moderate (kgroup 0.53, ksubgroup 0.49). Disagreement was found to arise between specific subgroups, which may be amenable to clarification.
A systematic review was conducted on 30 December 2014 to determine whether prophylactic antibiotics reduce the risk of superficial infection and osteomyelitis following open distal phalanx fractures. Four randomized controlled trials (353 fractures) were suitable for meta-analysis. There was no statistically significant difference between rates of superficial infection in the two groups. This finding persisted when only the two most recent and highest quality trials were included. There were no reported cases of osteomyelitis in the pooled dataset, despite patients with 164 fractures not receiving antibiotics. These results fail to show any effect of prophylactic antibiotics on the rate of superficial infections following open distal phalanx fractures. The focus of treatment should be on prompt irrigation and debridement rather than administration of prophylactic antibiotics.
Objective To assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires. Design Multicentre randomised clinical superiority trial, Setting 36 hospitals in the UK National Health Service (NHS). Participants 500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation). Interventions Manipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice. Main outcome measures The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks. Results The mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference −0.34 (95% confidence interval −4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). Conclusions Among patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients’ wrist function at 12 months compared with a cast. Trial registration ISRCTN registry ISRCTN11980540 .
IntroductionOptimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures.Methods and analysisAdult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either ‘manipulation and surgical fixation with K-wires’ or ‘manipulation and plaster casting’. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications.Ethics and DisseminationThe National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.Trial registration numberISRCTN11980540; Pre-results.
Background Patients with a displaced fracture of the distal radius are frequently offered surgical fixation. Manipulation of the fracture and moulded plaster casting is an alternative treatment that avoids metal implants, but evidence of its effectiveness is lacking. Objective To compare functional outcomes, quality-of-life outcomes, complications and resource use among patients with a dorsally displaced fracture of the distal radius treated with manipulation and surgical fixation with Kirschner wires (K-wires) and those treated with manipulation and moulded cast. Design Pragmatic, superiority, multicentre, randomised controlled trial with a health economic evaluation. Setting A total of 36 orthopaedic trauma centres in the UK NHS. Participants Patients (aged ≥ 16 years) treated for an acute dorsally displaced fracture of the distal radius were potentially eligible. Patients were excluded if their injury had occurred > 2 weeks previously, if the fracture was open, if it extended > 3 cm from the radiocarpal joint or if it required open reduction, or if the participant was unable to complete questionnaires. Interventions Participants were randomly assigned in theatre (1 : 1) to receive a moulded cast (i.e. the cast group) or surgical fixation with K-wires (i.e. the K-wire group) after fracture manipulation. Main outcome measures The primary outcome measure was the Patient-Rated Wrist Evaluation score at 12 months, analysed on an intention-to-treat basis. Health-related quality of life was recorded using the EuroQol-5 Dimensions, five-level version, and resource use was recorded from a health and personal social care perspective. Results Between January 2017 and March 2019, 500 participants (mean age 60 years, 83% women) were randomly allocated to receive a moulded cast (n = 255) or surgical fixation with K-wire (n = 245) following a manipulation of their fracture. A total of 395 (80%) participants were included in the primary analysis at 12 months. There was no difference in the Patient-Rated Wrist Evaluation score at 1 year post randomisation [cast group: n = 200, mean score 21.2 (standard deviation 23.1); K-wire group: n = 195, mean score 20.7 (standard deviation 22.3); adjusted mean difference –0.34 (95% confidence interval –4.33 to 3.66); p = 0.87]. A total of 33 (13%) participants in the cast group required surgical fixation for loss of fracture position in the first 6 weeks, compared with one participant in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). The base-case cost-effectiveness analysis showed that manipulation and surgical fixation with K-wires had a higher mean cost than manipulation and a moulded cast, despite similar mean effectiveness. The use of K-wires is unlikely to be cost-effective, and sensitivity analyses found this result to be robust. Limitations Because the interventions were identifiable, neither patients nor clinicians could be blind to their treatment. Conclusions Surgical fixation with K-wires was not found to be superior to moulded casting following manipulation of a dorsally displaced fracture of the distal radius, as measured by Patient-Rated Wrist Evaluation score. However, one in eight participants treated in a moulded cast required surgery for loss of fracture reduction in the first 6 weeks. After a successful closed reduction, clinicians may consider a moulded cast as a safe and cost-effective alternative to surgical fixation with K-wires. Future work Further research should focus on optimal techniques for immobilisation and manipulation of this type of fracture, including optimal analgesia, and for rehabilitation of the patient after immobilisation. Trial registration This trial is registered as ISRCTN11980540 and UKCRN Portfolio 208830. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 11. See the NIHR Journals Library website for further project information.
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. Results In the base case analysis, surgical fixation with K-wire was more expensive (£29.65 (95% confidence interval (CI) -94.85 to 154.15)) and generated lower QALYs (0.007 (95% CI -0.03 to 0.016)) than moulded casting, but this difference was not statistically significant. The probability of K-wire being cost-effective at a £20,000 per QALY cost-effectiveness threshold was 24%. The cost-effectiveness results remained robust in the sensitivity analyses. Conclusion The findings suggest that surgical fixation with K-wire is unlikely to be a cost-effective alternative to a moulded cast in adults, following manipulation of a fracture of the distal radius in a theatre setting. Cite this article: Bone Joint J 2022;104-B(11):1225–1233.
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