Three-Dimensional Corrective Osteotomy for Malunited Fractures of the Upper Extremity Using Patient-Matched Instruments: A Prospective, Multicenter, Open-Label, Single-Arm Trial.

ABSTRACT

BACKGROUND: Medical image processing has facilitated simulation of 3-dimensional (3-D) corrective osteotomy, and 3-D rapid prototyping technology has further enabled the manufacturing of patient-matched surgical guides and implants (patient-matched instruments, or PMIs). However, 3-D corrective osteotomy using these technologies has not been the standard procedure. We aimed to prospectively verify the efficacy and safety of PMIs in corrective osteotomy for deformities of the upper extremity. METHODS: We enrolled 16 patients with a total of 17 bone deformities in the upper extremity. Eight patients had distal radial malunion; 5, distal humeral malunion; and 3, forearm diaphyseal malunion. All cases underwent 3-D corrective osteotomy with PMIs. The primary end point was the residual maximum deformity angle (MDA), which was calculated from 2 deformity angles-1 on the anteroposterior and 1 on the lateral postoperative radiograph. Secondary end points included the deformity angle on radiographs, 3-D error between the preoperative planning model and the postoperative result, range of motion, grip strength, pain measured with a visual analog scale (VAS), patient satisfaction, and Disabilities of the Arm, Shoulder and Hand (DASH) score. RESULTS: The average MDA significantly improved from 25.5° preoperatively to 3.3° at the final follow-up (p < 0.001). The angular deformity was within 5° in all cases, except for 1 with distal radial malunion who had a higher angle on the anteroposterior radiograph. The error between the correction seen on the postoperative 3-D bone model and the planned correction was <1° and <1 mm. Flexion and extension of the wrist and pronation of the forearm of the patients treated for distal radial malunion improved significantly, and pronation improved for those treated for forearm diaphyseal malunion. The average VAS score, grip strength, and DASH score significantly improved as well. Of the 16 patients, 15 were very satisfied or satisfied with the outcomes. CONCLUSIONS: Corrective osteotomy using PMIs achieved accurate correction and good functional recovery in the upper extremity. Although our study was limited to cases without any deformity on the contralateral side, 3-D corrective osteotomy using PMIs resolved treatment challenges for complex deformities in upper extremities. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.