Intra-Articular Corrective Osteotomy for Distal Radial Intra-Articular Malunion Using Patient-Matched Instruments: A Prospective, Multicenter, Open-Label, Single-Arm Trial.

Background: Corrective osteotomy for intra-articular malunion is a challenging procedure. However, recent advancements, including patient-matched instruments created on the basis of preoperative computer simulation, enable accurate intra-articular correction. We hypothesized that intra-articular corrective osteotomy using patient-matched instruments for the treatment of distal radial intra-articular malunion would reduce intra-articular deformity and restore wrist function at 12 months of follow-up. Methods: This prospective study included 12 patients with distal radial intra-articular malunion who underwent intra-articular corrective osteotomy external to the joint using patient-matched instruments. The primary end point was the maximum step-off on the articular surface of the distal radius, measured with use of computed tomography (CT), with an expected postoperative value of ≤1.5 mm. The secondary end points included the gap of the articular surface; range of motion; grip strength; pain evaluated using a visual analog scale (VAS); patient satisfaction; Disabilities of the Arm, Shoulder and Hand (DASH) score; and Patient-Rated Wrist Evaluation (PRWE) score. A mean postoperative step-off of ≤1.5 mm for the primary end point was assessed with use of the 1-sample t test. The secondary end points were assessed with use of the Dunnett multiple comparison test. Results: The average step-off significantly improved from 3.75 ± 1.04 mm preoperatively to 0.51 ± 0.40 mm at the 52-week postoperative follow-up and was maintained within 1.5 mm. The average wrist and forearm range of motion, VAS score, grip strength, DASH score, and PRWE score significantly improved. Eleven patients were either very satisfied or satisfied with their outcomes. Conclusions: The use of patient-matched instruments could contribute to improving postoperative outcomes of intra-articular corrective osteotomy procedures involving the distal radius. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.