The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL

Study Overview
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Brief Summary
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Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.

Detailed Description
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The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. 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 the Modified Broström vs Anatomic Reconstruction 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: Modified Broström operation and anatomic reconstruction 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Modified Broström operation group<br>Patients who accept a modified Broström operation | Procedure: Modified Broström operation and anatomic reconstruction operation<br>* Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.<br>|
| Anatomic reconstruction operation group<br>Patients who accept an anatomic reconstruction | Procedure: Modified Broström operation and anatomic reconstruction operation<br>* Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction 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, re-injury, modified Brostrom operation, anatomic reconstruction