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

Recruiting

• Conditions: Ankle Sprain; Hypermobility, Joint

• Registration Number: NCT06897293
• Lead Sponsor: Peking University Third Hospital

Brief Summary

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.

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 may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-26
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

• Patients with an acute or subacute ankle injury
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The American Orthopaedic Foot and Ankle Society (AOFAS) score	postoperative AOFAS score at 3 months	This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

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, and can be evaluated through same stress radiography
Rate of re-injury	the rate of re-injury at 2 years	The rate of patients re-sprain after the surgery

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China