Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Radiological outcomes following surgical fixation with wires versus moulded cast for patients with a dorsally displaced fracture of the distal radius: a radiographic analysis from the DRAFFT2 trial.

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.

Effect of Alendronic Acid on Fracture Healing: A Multicenter Randomized Placebo-Controlled Trial.

There is a concern that bisphosphonates may impair fracture healing because of their inhibitory effects on bone turnover. Here we evaluated the effects of early bisphosphonate therapy on fracture healing and functional outcome following a fracture of the distal radius. The fracture and bisphosphonates (FAB) trial was a double-blind, randomized, placebo-controlled trial involving 15 trauma centers in the United Kingdom. We enrolled 421 bisphosphonate-naive patients aged ≥50 years with a radiographically confirmed fracture of the distal radius and randomized them in a 1:1 ratio to receive alendronic acid 70 mg once weekly (n = 215) or placebo (n = 206) within 14 days of the fracture. The primary outcome measure was the proportion of fractures that had radiologically united at 4 weeks as assessed by an observer, blinded to treatment allocation. Secondary outcomes included the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire, range of wrist movement and grip strength, pain and analgesia requirements, and the rate of malunion. The mean ± SD age of participants was 63 ± 8.5 years and 362 (86%) were female. At 4 weeks, 48 of 202 (23.8%) fractures had united in the alendronic acid group compared with 52 of 187 (27.8%) in the placebo group (observed absolute proportion difference 4.0%; 95% CI, -4.7% to 12.8%; p = 0.36). The absolute proportion difference between groups based on imputed data was 4.5% (95% CI, -4.7% to 13.8%; p = 0.30). There was no significant difference in the proportion of fractures that had united at any other time point and no differences in the DASH score, pain at the fracture site, grip strength, or any other clinical outcome. We conclude that among patients aged 50 years and above with a distal radius fracture, early administration of alendronic acid does not adversely affect fracture union or clinical outcome. These findings suggest bisphosphonate therapy can be safely commenced early after fracture if clinically indicated. © 2019 American Society for Bone and Mineral Research.

Limb lengthening by the Vilarrubias method: the Sheffield Children's Hospital experience.

The Vilarrubias method of limb lengthening is a percutaneous procedure with soft tissue releases. This reduces soft tissue tension and prevents joint contractures during longer lengthenings. This method has been used for 99 lower limb lengthenings. The mean length gained was 92 mm and the mean Bone Healing Index was 41.3 days/cm. There were 45 pin site problems, 33 flexion contractures, 33 angular deformities and 15 stress fractures. This complication rate compares well with other techniques. We recommend that the Vilarrubias method can be considered for lengthenings, where the aim is greater than 15% of the bone length with potential soft tissue problems.

The radiographic classification of the bone-screw interface in paediatric tibial lengthening.

Bone-screw loosening in monolateral external fixators is a significant problem. This study classifies the radiographic appearance of the bone-screw interface and predicts which screws will become loose and those that will remain solidly fixed to bone. Five radiographic features were identified at the bone-screw interface. The classification of these features was validated using interobserver and intraobserver studies. The reliability of the classification was improved by image enhancement with simple filters. Some radiographic features predicted which screws would eventually become loose, allowing the clinician to make earlier management decisions regarding the adjustment of screws.

Tibial lengthening: does the fibula migrate?

A retrospective study of 32 patients who underwent tibial lengthening was performed in order to establish the need for distal tibio-fibular fixation. In 16 patients stabilization of the inferior tibio-fibular joint was carried out and in the other 16 no stabilization was performed. Three established and one new radiographic index of the tibio-fibular relationship at the ankle were used to assess proximal fibular migration. All patients showed proximal migration of the distal fibula, but those without stabilization demonstrated marked migration of the fibula associated with a valgus tendency. The difference between the groups was statistically significant ( <0.001), confirming the need for fibular fixation.

Management of tibial non-union with tricalcium phosphate and BMP 7.

We present the case of a 30-year-old woman who was referred with an established tibial non-union with a bone defect following a spiral fracture of the tibia. Initial attempts at union with intramedullary fixation and then autograft were unsuccessful. We achieved union by debriding the fibrous tissue and packing the defect with Bone Morphogenetic Protein 7 (Osigraft, Stryker, UK) and a tricalcium phosphate bone void filler (Calstrux, Stryker, UK). We did not use any additional surgical fixation and the patient was supported in an aircast boot.

Radiographic assessment of bone formation in tibia during distraction osteogenesis.

The radiologic appearance of bone formation during limb lengthening is used to judge the competence of the underlying biologic process and predict the likely time to healing. Interpretation is, however, based upon subjective parameters that have never been clearly defined. Thirty anteroposterior radiographs from pediatric tibial lengthenings were classified by four pairs of surgeons using a three-part system. Across the group, interobserver consistency showed considerable variation for all parameters tested. Pairwise analysis indicated that the surgeons directly involved in limb lengthening procedures agreed better than those whose practice was of a different nature. A second series of radiographs contained 12 radiographs with a satisfactory and 12 with a poor bone healing index (BHI). These radiographs were digitized, and an interobserver study showed significantly improved observer concordance if the images were enhanced. No feature was associated with a 100% chance of a satisfactory outcome, but certain appearances in the regenerate were associated with a better BHI than others.