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

Recruiting

• Conditions: Ankle Sprains; Instability, Joint; Joint Hypermobility
• Interventions: Procedure: Modified Broström operation and anatomic reconstruction operation

• Registration Number: NCT05196906
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-16
• Study First Posted: 2022-01-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anatomic reconstruction operation group	Modified Broström operation and anatomic reconstruction operation	Patients who accept an anatomic reconstruction
Modified Broström operation group	Modified Broström operation and anatomic reconstruction operation	Patients who accept a modified Broström operation

Primary Outcome Measures

Name	Time	Method
Karlsson score	postoperative Karlsson score at 2 years.	This score is a primary scale for lateral ankle instability

Secondary Outcome Measures

Name	Time	Method
Anterior displacement and talar tilt angle in stress radiography	postoperative radiographic measures at 2 years.	The outcomes are common indicators for evaluation the lateral stability of ankle

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China