Post-traumatic elbow stiffness
Conditions
Interventions
Arthroscopic Release (AR) Group:The AR procedure follows standard arthroscopic arthrolysis techniques as described by O’Driscoll et al.
Open Arthrolysis (OA) Group:Traditional open surgical release of elbow contracture.
Sponsors
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adults (age >= 18 years, any sex) with post-traumatic elbow stiffness (PTES), defined as per criteria: flexion-extension arc 30°, attributable to prior elbow trauma (fracture, dislocation, ligament injury, etc.). 2.Elbow stiffness persists despite 6 to 12 months of non-operative management (physical therapy, splinting, etc.), indicating failure of conservative treatment. 3.Time since injury >= 12 months (to allow maximal natural recovery and confirm chronic stiffness). 4.Functional impairment: The stiffness causes significant functional limitation in daily activities (e.g., personal hygiene, feeding, work tasks) as determined by patient report and physician assessment. 5.Radiographic evaluation confirming no complete bony ankylosis (some joint motion exists) and that the joint is amenable to release (presence of joint space on imaging). 6.Willingness to undergo either surgical procedure per random assignment and to comply with postoperative rehabilitation and follow-up visits. 7.Provided written informed consent after understanding the trial procedures, risks, and benefits.
Exclusion criteria
Exclusion criteria: 1.Neurological deficits in the affected arm: e.g., unresolved ulnar or median nerve palsy or brachial plexus injury that impairs motor function or sensation, which could confound outcome assessment. 2.Extensive heterotopic ossification (HO): radiographically severe HO that bridges the joint or is deemed by the surgeon to require an open approach for adequate removal. These patients are not suitable for arthroscopic release due to limited space and visibility. 3.Prior surgery on the affected elbow for stiffness (excluding initial trauma fixation). Prior release could alter soft tissue planes or scarring, affecting outcomes. 4.Joint infection: Active or previous septic arthritis in the elbow, due to risk of reactivation and because treatment would involve different protocols. 5.Inflammatory arthritis or systemic conditions (e.g., rheumatoid arthritis) affecting the elbow, which could independently cause stiffness and confound results. 6.Fracture non-union or malunion at the elbow requiring concurrent correction – trial targets contracture release only. 7.Unstable elbow or ligament insufficiency requiring reconstructive procedures (should be stabilized prior to or separate from contracture release). 8.Severe osteoporosis or other contraindications to surgery/anesthesia (e.g., uncontrolled diabetes, severe cardiac conditions) as determined by preoperative evaluation. 9.Pregnancy: Pregnant women are excluded for safety (though unlikely given age and condition, any woman of childbearing potential will be tested and excluded if pregnant). 10.Inability to consent or comply: cognitive impairment, psychiatric conditions, or other issues that preclude understanding the study or adhering to rehab protocol. 11.Patient refusal or preference override: if the patient is unwilling to accept random assignment and insists on a particular treatment, they cannot be ethically randomized.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elbow Range of Motion (ROM);Health Economic Outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Isometric Flexion Strength;Flexion Endurance;American Shoulder and Elbow Surgeons (ASES) Elbow Score;Disabilities of the Arm, Shoulder and Hand (DASH) Score;Complications and Adverse Events; | — |
Countries
China
Contacts
Public ContactDing Jian
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed