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.