Multicenter trial of an internal joint stabilizer for the elbow

Background Our primary efficacy objective was to evaluate the effectiveness of the internal joint stabilizer of the elbow (IJS-E) in maintaining concentric location of the elbow during and after removal of the device in the treatment of persistent or recurrent instability after elbow fracture or dislocations, or both. The secondary study objectives were to assess range of motion, Broberg-Morrey functional score, Broberg-Morrey categorical rating, the Disabilities of the Arm, Shoulder and Hand score, and the rate of complications and adverse events after the use of IJS-E. Methods Twenty-four patients were studied in a multicenter, nonrandomized, prospective, single-arm study. The IJS-E was used to provide temporary stabilization of the elbow joint and allow a functional range of motion while ligaments and fractures healed. Results The elbow remained concentrically aligned in 23 of 24 patients. One coronoid-deficient elbow did not maintain concentric reduction. At the last evaluation a minimum of 6 months after device removal, the mean arc of elbow flexion was 119° (range, 80°-150°; standard deviation [SD], 18°), and the mean arc of forearm rotation was 151° (range, 90°-190°; SD, 24°). The mean and median Broberg-Morrey scores were 93 and 97, respectively. Categorically the results were excellent in 14, good in 8, fair in 1, and poor in 1. The mean Disabilities of the Arm, Shoulder and Hand score was 16 (range, 0-68; SD, 18). Conclusion The IJS-E maintains concentric reduction, allows elbow motion, and avoids the inconveniences and pin problems of percutaneous fixation.