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

May 18, 2026 updated by: Jiang Dong, Peking University Third Hospital

Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 15 - 55 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Modified Broström +Suture tape augmentation group
Patients who accept a modified Broström procedure + Suture tape augmentation operation
Procedure: Modified Broström procedure + Suture tape augmentation operation
Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation
Open Modified Broström group
Patients who accept a modified Broström procedure operation
Procedure: Modified Broström procedure operation
Patients with CLAI and GJL will accept the Modified Broström procedure operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time Frame: postoperative AOFAS score at 1 year
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.
postoperative AOFAS score at 1 year
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time Frame: postoperative AOFAS score at 2 years
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.
postoperative AOFAS score at 2 years
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time Frame: postoperative AOFAS score at 6 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.
postoperative AOFAS score at 6 months
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time Frame: 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.
postoperative AOFAS score at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior displacement and talar tilt angle in stress radiography
Time Frame: 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
postoperative radiographic measures at 2 years
Rate of re-injury
Time Frame: the rate of re-injury at 2 years
The rate of patients re-sprain after the surgery
the rate of re-injury at 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to noise value of anterior talofibular ligament
Time Frame: 6 months post-treatment
Signal to noise value of the anterior talofibular ligament
6 months post-treatment
Signal to noise value of the anterior talofibular ligament
Time Frame: 12 months post-treatment
Signal to noise value of the anterior talofibular ligament
12 months post-treatment
Signal to noise value of the anterior talofubular ligament
Time Frame: 24 months post-treatment
Signal to noise value of the anterior talofibular ligament
24 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2024292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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