Comparison of MBR + Suture Tape and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study

Recruiting

• Conditions: Hypermobility Syndrome; Ankle Sprains
• Interventions: Procedure: Modified Broström + Suture tape augmentation operation; Procedure: Anatomic reconstruction operation

• Registration Number: NCT05698446
• Lead Sponsor: Peking University Third Hospital

Brief Summary

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Detailed Description

Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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
Open Modified Broström +Suture tape augmentation group	Modified Broström + Suture tape augmentation operation	Patients who accept a modified Broström +Suture tape augmentation operation
Anatomic reconstruction operation group	Anatomic reconstruction operation	Patients who accept an anatomic reconstruction

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