Coracoclavicular ligament reconstruction versus hook plate treatment in patients with Rockwood III-VI acute acromioclavicular dislocation: a multicentre randomized controlled trial

BACKGROUND: In 9-12% of shoulder girdle injuries in athletes, acromioclavicular (AC) joint dislocations disproportionately affect young adults who are engaged in contact sports. Surgical reconstruction has emerged as the gold standard for Rockwood III-VI lesions, particularly in professional athletes, where conservative management is correlated with high recurrence rates according to recent meta-analyses. However, the optimal surgical management for acute Rockwood type III-VI AC dislocations remains controversial, with no consensus on the most effective technique. This study aims to evaluate the efficacy of two prevalent surgical techniques: hook plate fixation and coracoclavicular ligament reconstruction using a ligament augmentation and reconstruction system (LARS). METHODS: This study is designed as a multicentre, single-blinded, two-arm, parallel-group randomized controlled superiority trial with a 1:1 allocation ratio. Hook plate (arm 1) and LARS ligament (arm 2) will be compared. The primary outcome will be the Disability Arm Shoulder and Hand (DASH) score. The secondary outcomes will include imaging evaluations of re-dislocation, the quality of life 12-item survey questionnaire (SF-12), the visual analog scale (VAS), the Constant-Murley-Shoulder joint score, and complications. Since treatment allocation involves surgery and X-ray access for patients and surgeons, only researchers who analyze the outcome data after 1 year of follow-up will be blinded to the allocation. A total of 72 participants will be included, and the estimated time to complete this trial will be approximately 2 years. All the work will be conducted at the National Orthopedic Medical Center and its partner trauma healthcare network. DISCUSSION: As the optimal surgical method for severe AC joint dislocation remains uncertain, this study highlights the differences in short-term and middle-term outcomes between hook plate and LARS ligament surgical treatments, which may hopefully reveal the most effective surgical interventions. TRIAL REGISTRATION: This study is registered at the Chinese Clinical Trial Registry (ChiCTR2400082168) and was granted permission by the institutional ethics committee of Shanghai Sixth People's Hospital on 02-29-2024. https://www.chictr.org.cn/showproj.html?proj=222307.