A multicentre, randomized, double-blind trial of the safety and efficacy of mannose-6-phosphate in patients having Zone II flexor tendon repairs

Abstract

The safety, tolerability and preliminary efficacy of mannose 6-phosphate in enhancing the outcome in Zone II flexor tendon repair was studied in a multicentre parallel double-blinded randomized controlled trial. Eight UK teaching hospitals were involved in treating repaired flexor tendons with a single intraoperative intrathecal dose of 600 mM mannose 6-phosphate, with follow-up over 26 weeks. A total of 39 patients (mannose 6-phosphate, n = 20; standard care, n = 19) were randomized. Seven were excluded from the safety and tolerability analysis because of intraoperative findings and eight were excluded due to early dropout ( n = 4) or tendon rupture ( n = 4), leaving 24 (mannose 6-phosphate, n = 13; standard care, n = 11) for assessment of total active motion. The safety, tolerability and other side effects were comparable between the groups. There was no significant difference between the two groups in the total active motion at Week 26. We concluded that mannose 6-phosphate, although safe and tolerable, had no beneficial effect on finger range of motion after Zone II tendon division. Level of evidence 1b