Functional outcome after corrective osteotomy for malunion of the distal radius: a randomised, controlled, double-blind trial

PURPOSE: The purpose of this randomised, controlled, double-blind trial was to evaluate functional outcome during the first year after corrective osteotomy for malunited distal radius fractures, with or without filling the osteotomy void. METHOD: Patients were randomised to receive a HydroSet bone substitute or no graft. Cortical contact was maintained and stabilisation of the osteotomy was carried out with a DiPhos R- or RM Plate. To evaluate subjective functional outcome, the Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH), the Canadian Occupational Performance Measure (COPM) and the RAND-36 were used. Moreover, range of motion and grip strength were measured by blinded evaluators. Evaluations were made pre-operatively and three, six and 12 months post-operatively. RESULTS: There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05). In both groups, there was a significant improvement at the 12-month follow-up compared with pre-operatively for the PRWE, the Q-DASH and the COPM satisfaction scores. The RAND-36 revealed no significant differences except for two domains, in which there was an improvement in the treatment group (p < 0.05). For grip strength and for range of motion in all movement directions, except dorsal extension, there was a significant improvement in both groups (p < 0.05). CONCLUSION: There is no significant difference in functional outcome during the first year after corrective open-wedge distal radius osteotomy, where cortical contact is maintained, regardless of whether or not bone substitute to fill the void is used.