Currently submitted to: JMIR Research Protocols
Date Submitted: Oct 8, 2026
Open Peer Review Period: Oct 9, 2026 - Dec 4, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Operative Versus Conservative Management of Displaced Lateral End Clavicle Fractures in Adults: Protocol for an Exploratory Randomized Controlled Trial
ABSTRACT
Background:
Displaced lateral end clavicle fractures with disruption of the coracoclavicular ligaments carry a high risk of nonunion when treated without surgery. Despite this, observational studies, systematic reviews, and 1 multicenter randomized trial have reported similar shoulder function after operative and conservative care. Surgery improves union at the cost of implant-related complications and frequent secondary procedures. Randomized evidence remains scarce, and none comes from resource-limited settings where many patients return early to manual work.
Objective:
This exploratory trial aims to estimate the difference in shoulder function, pain, disability, radiographic union, and complications between operative fixation and conservative management of displaced lateral end clavicle fractures in adults over 6 months, and to assess the feasibility of a definitive trial.
Methods:
This is a single-center, open-label, parallel-group randomized controlled trial with 1:1 allocation and blinded assessment of the primary outcome, conducted at a rural tertiary teaching hospital in central India. Forty adults aged 25 to 80 years with an acute displaced lateral end clavicle fracture (Neer type II or V) will be randomized to operative fixation (precontoured locking plate, with coracoclavicular augmentation or a hook plate according to prespecified criteria) or conservative management in a broad arm sling. Both groups will follow the same physiotherapy protocol. The primary outcome is the Constant-Murley score at 6 months. Secondary outcomes include the Disabilities of the Arm, Shoulder and Hand (DASH) score, visual analog scale pain, radiographic union, complications, secondary interventions, return to work, and patient satisfaction. The primary estimand follows a treatment-policy strategy and will be estimated with a linear mixed-effects model. The sample size provides 80% power only for a large standardized difference (Cohen d of about 1.0), so all comparisons will be interpreted as estimates that inform a future definitive trial.
Results:
The trial was prospectively registered with the Clinical Trials Registry of India on November 27, 2025, and received approval from the Institutional Ethics Committee on June 30, 2025. Recruitment started from 1 December 2025, as of October 2026 35 participants has been recruited, expected completion of recruitment and follow-up June 2027. Results will be published once data collection and analysis gets completed.
Conclusions:
This trial will provide randomized estimates of the trade-off between union and implant-related morbidity in displaced lateral end clavicle fractures in a resource-limited setting, and will inform the design of an adequately powered trial. Clinical Trial: Clinical Trials Registry of India CTRI/2025/11/098154
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