The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

Conditions
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Ankle Sprains, Instability, Joint, Joint Hypermobility

Intervention / Treatment
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* Procedure: Open or arthroscopic Modified Broström operation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Modified Broström operation group<br>Patients who accept an open modified Broström operation | Procedure: Open or arthroscopic Modified Broström operation<br>* Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.<br>|
| Active Comparator: Arthroscopic Modified Broström operation group<br>Patients who accept an arthroscopic modified Broström operation | Procedure: Open or arthroscopic Modified Broström operation<br>* Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karlsson score | This score is a primary scale for lateral ankle instability | postoperative Karlsson score at 1 year | 
| Karlsson score | This score is a primary scale for lateral ankle instability | postoperative Karlsson score at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior displacement and talar tilt angle in stress radiography | The outcomes are common indicators for evaluation the lateral stability of ankle | postoperative radiographic measures at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic lateral ankle instability, generalized joint laxity, modified Brostrom operation, arthroscopic, open