The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Karlsson score
Study Overview
Brief Summary
Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.
Detailed Description
The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot & Ankle Society, and visual analogue scales. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Randomization was achieved using the opaque sealed envelopes, and each eligible patient was allocated to open or arthroscopic MBP in a 1:1 ratio with a random block assignment of 4 or 6. The envelopes were thoroughly shuffled and sequentially numbered and then opened before surgery. Patients were allowed to withdraw from this experiment.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years
Exclusion Criteria
- •Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
Outcomes
Primary Outcomes
Karlsson score
Time Frame: postoperative Karlsson score at 2 years
This score is a primary scale for lateral ankle instability
Secondary Outcomes
- Anterior displacement and talar tilt angle in stress radiography(postoperative radiographic measures at 2 years)
Investigators
Jiang Dong
Chief physician
Peking University Third Hospital