Dupuytren's interventions surgery versus collagenase (DISC) trial: study protocol for a pragmatic, two-arm parallel-group, non-inferiority randomised controlled trial.

BACKGROUND: Dupuytren's contracture is a fibro-proliferative disease of the hands affecting over 2 million UK adults, particularly the white, male population. Surgery is the traditional treatment; however, recent studies have indicated that an alternative to surgery-collagenase clostridium histolyticum (collagenase)-is better than a placebo in the treatment of Dupuytren's contracture. There is however no robust randomised controlled trial that provides a definitive answer on the clinical effectiveness of collagenase compared with limited fasciectomy surgery. Dupuytren's intervention surgery vs collagenase trial (DISC) trial was therefore designed to fill this evidence gap. METHODS/DESIGN: The DISC trial is a multi-centre pragmatic two-arm parallel-group, randomised controlled trial. Participants will be assigned 1:1 to receive either collagenase injection or surgery (limited fasciectomy). We aim to recruit 710 adult participants with Dupuytren's contracture. Potential participants will be identified in primary and secondary care, screened by a delegated clinician and if eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported patient evaluation measure assessed 1 year after treatment. Secondary outcome measures include the Unité Rhumatologique des Affections de la Main Scale, the Michigan Hand Questionnaire, EQ-5D-5L, resource use, further procedures, complications, recurrence, total active movement and extension deficit, and time to return to function. Given the limited evidence comparing recurrence rates following collagenase injection and limited fasciectomy, and the importance of a return to function as soon as possible for patients, the associated measures for each will be prioritised to allow treatment effectiveness in the context of these key elements to be assessed. An economic evaluation will assess the cost-effectiveness of treatments, and a qualitative sub-study will assess participants' experiences and preferences of the treatments. DISCUSSION: The DISC trial is the first randomised controlled trial, to our knowledge, to investigate the clinical and cost-effectiveness of collagenase compared to limited fasciectomy surgery for patients with Dupuytren's contracture. TRIAL REGISTRATION: Clinical.Trials.gov ISRCTN18254597 . Registered on April 11, 2017.

Outcomes and Early Recurrence Following Enzymatic (Collagenase) Treatment of Moderate and Severe Dupuytren Contractures.

PURPOSE: We offer collagenase Clostridium histolyticum (CCH) injections to all patients with a Dupuytren contracture and a palpable cord. We assessed whether more severe contractures respond less well or recur more frequently. METHODS: From a database of 502 CCH injections, 386 (77%) had a complete dataset with minimum 1-year face-to-face follow-up. Contracture severity was assessed using the Tubiana system: grade 1 (27%), grade 2 (49%), grade 3 (19%), and grade 4 (5%). Patients received a single intralesional injection of 0.58 mg CCH followed by manipulation. Finger position was measured at 6 to 12 weeks, 6 months, and 1 year. Failure to break the cord, skin tears, and any adverse events were noted. Recurrence was defined as a failure to maintain any prior correction to within 20°. RESULTS: There were 17 failures (4%) and 6 allergic reactions (1%). We found 31% corrected completely, with approximately half remaining corrected at 1 year. We achieved 43° (95% confidence interval, 40°-46°) correction of combined deformity, with 11° (95% confidence interval, 9°-13°) correction attrition over 1 year. Sixteen percent of treated digits experienced a recurrence with no difference between Tubiana grades, and one-third chose further treatment. Following treatment, Tubiana grade 1 contractures improved by 78% in comparison with higher grade contractures (55%-67% relative correction). By 1 year, all grades had a similar mean 46% relative correction. A complete correction was seen in 61% of grade 1 contractures, with more severe contractures less likely to correct completely (9%-24%). A 31% skin tear rate had no impact on outcome, recurrence, or long-term morbidity. CONCLUSIONS: CCH may treat any Dupuytren cord regardless of severity. Although contracture may recur, few patients pursue further treatment within 1 year. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Volar Buttress Plating for Unstable Dorsal Fracture-Dislocations of the Proximal Interphalangeal Joint.

The authors present a series of 11 patients. All of them sustained an unstable dorsal fracture-dislocation of the proximal interphalangeal joint (PIPJ). These were managed with open reduction and internal fixation (ORIF) by use of an eight-hole, 1.3-mm oblique-angled strut plate, cut to shape to produce a four-hole plate, acting as a buttress plate. The operations were performed by orthopaedic surgeons with a special interest in hand surgery. Range of motion (ROM) and fixed flexion deformity (FFD) were measured postoperatively. Outcomes were assessed using the Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) scoring system. Bony union, articular step-off, degenerative changes, persistent subluxation, or dislocation were confirmed by review of radiographs at latest follow-up. One patient developed a superficial infection and another developed complex regional pain syndrome. However, all patients were pain free at final follow-up. Radiographs at final follow-up confirmed bony union with no step-off, except for one patient who had a 1-mm step-off of the articular surface. Our attractive and novel technique of ORIF allows articular congruity to be restored anatomically with early active mobilization of the affected digit and early return to function.

Scaphoid Nonunion With Poor Prognostic Factors: The Role of the Free Medial Femoral Condyle Vascularized Bone Graft.

Background: To report on the results of free medial femoral condyle (MFC) vascularized bone graft for scaphoid nonunions with 1 or more poor prognostic factors. Methods: We have used the free MFC vascularized bone graft for scaphoid nonunions that have 1 or more factors associated with a poor prognosis. These were, a delay in presentation of over 5 years, a proximal pole nonunion, the presence of avascular necrosis (AVN), or previous nonunion surgery. We used this technique on 20 patients over a 4.5-year period. Results: Our overall union rate was 88.5% (17 of 19 patients), with 1 patient failing to attend for follow-up. Our mean union time was 7 months (2-18). All patients had at least 1 poor prognostic factor and over half had 2 or more. Of those with AVN with or without other factors, the union rate was 85% (11 of 13). There were 2 donor site complications that required a further procedure and 2 patients with residual wrist pain that required a scapho-trapezio-trapezoid joint fusion and a radial styloidectomy, respectively. Both nonunions were offered further surgery, and 1 elected to undergo successful revision surgery. Conclusions: Overall, this technique showed good results, in a subgroup of patients that typically have poorer outcomes, with a low incidence of donor site morbidity. Our union rate compares favorably with other techniques for this difficult subset of patients with 1 or more poor prognostic factors, although results are clearly not as good as those of studies using the MFC graft for all scaphoid nonunions. We continue to reserve this technique for nonunions with 1 or more poor prognostic factors, and we believe that this technique should at least be considered in these patients.

Stability of Unicortical versus Bicortical Metacarpal Fracture Internal Fixation Trial (SUBMIT): study protocol for a randomized controlled trial.

BACKGROUND: Metacarpal fractures are common, accounting for 40 % of all hand injuries. The use of plates for the fixation of these fractures allows early aggressive hand therapy post-operatively, reducing post-operative stiffness. Traditionally, bicortical fixation is the standard practice, where both dorsal and palmar cortices of the metacarpal are drilled through, with screws engaging both cortices. Recent biomechanical studies have shown that unicortical fixation, where only the near cortex is drilled and engaged by the screw, results in no difference in stiffness, load to failure or failure mechanism, when compared with bicortical fixation. This trial aims to compare fracture union, complication rate and functional outcomes between unicortical and bicortical fixation for adults with displaced metacarpal fractures. METHODS/DESIGN: All adults with displaced diaphyseal metacarpal fracture requiring plate fixation are potentially eligible to take part in this study. A total of 315 consenting patients will be randomly allocated to either unicortical or bicortical plate and screw fixation. The surgery will be performed in specialist hand trauma units across the UK. Data regarding fracture healing, hand function, quality of life, and complications will be collected at 2 weeks, 6 weeks and 6 months following surgery. DISCUSSION: This pragmatic, prospective, multi-centre, randomized controlled trial is expected to deliver results in 2018. TRIAL REGISTRATION: ISRCTN 18006607 . Registered on 19 Nov 2015.