Xiapex is a novel non-surgical intervention for the treatment of Dupuytren's contracture. It comprises a fixed-ratio mixture of two purified collagenolytic enzymes (AUX-I [clostridial type I collegenase] and AUX II [clostridial type II collagenase]) isolated from the medium of The objectives of this study were to evaluate the safety and efficacy of Xiapex in patients with Dupuytren's Contracture, the recovery and associated use of health care resources. The study commenced in June 2011 and was completed in 11 months. 15 patients were screened for the study, 12 patients were eligible (10 male:2 female). All 12 patients completed the trial and 2 patients received multiple injections, one had two fingers affected and the other had two joints affected in one finger. Following screening visit to determine patient suitability, the patient received their first injection usually within 7 days. Xiapex was injected directly into the palpable cord. 24 hours after injection patients were reviewed and a “finger extension procedure” was performed if the cord had not spontaneously ruptured. Patients were then followed up at 7 days, 30 days and 6 months. Assessments at each visits included: Finger Goniometry, Physician and Subject Global Assessment and Satisfaction, Health Care Resource Utilization and URAM (function assessment) and adverse events. Of the 14 cords injected all ruptured after finger extension. No patient experienced any serious adverse events, but a number of more minor adverse events were recorded including skin tears, pain at injection site, swelling and bruising. At the time of final follow-up recurrence rates were 14% In conclusion, Xiapex is suitable for appropriately selected patients who are affected by Dupuytren's contractures and who have a well-developed palpable cord.
This multi-centre single-blind randomised control trial compared outcomes in patients with acute displaced mid-shaft clavicle fractures treated either by primary open reduction and plate fixation (ORPF), or non-operative treatment (NT). Two-hundred patients were randomised to receive either ORPF or NT. Functional assessment was conducted up to one-year using DASH, SF-12 and Constant scores (CS). Union was evaluated using radiographs and CT. Rate of non-union was significantly reduced after ORPF (1 following ORPF, 16 following NT, odds ratio=0.07, 95% CI=0.01–0.50, p=0.0006). 7 patients had delayed-union after NT. Group allocation to ORPF was independently predictive of development of non-union. DASH and CS were significantly better in the ORPF group 3-months post-surgery, but not at one-year (mean DASH = 6.2 after NT versus 3.7 after ORPF, p=0.09; mean CS = 86.1 after NT versus 90.7 after ORPF, p=0.05). Group allocation was not predictive of one-year outcome. Non-union was the only factor independently predictive of one-year functional outcome. There were no significant differences in time off work or subjective scores. Five patients underwent revision for complications after ORPF. 10 patients underwent metalwork removal. Treatment cost was significantly greater after ORPF (p=0.001). ORPF reduces rate of non-union compared with NT and is associated with better early functional outcomes. Improved outcomes are not sustained at one-year. Differences in functional outcome appear to be mediated by prevention of non-union from ORPF. ORPF is more expensive and associated with implant-related complications not seen with NT. Our results do not support routine primary ORPF for displaced mid-shaft clavicle fractures.
