Actively Recruiting

Age: 15Years - 55Years
All Genders
ID06897293

Comparison of Modified Brostrf6m Repair With and Without Suture Tape Augmentation for Chronic Lateral Ankle Instability: A Prospective Cohort Study

Led by Peking University Third Hospital · Updated on 2026-05-20

86

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

This research focuses on chronic lateral ankle instability (CLAI), a condition where the ankle frequently gives way, often worsened by generalized joint laxity (GJL). Researchers are exploring whether adding suture tape to the modified Brostrf6m repair (MBR), a surgical method for CLAI, can provide better ankle stability and strength. The study aims to understand the outcomes and possible risks, such as suture tape rejection, associated with this surgical augmentation. Participants will undergo one of two surgical procedures: the open modified Brostrf6m repair with suture tape augmentation or the standard modified Brostrf6m repair alone. Both groups consist of patients diagnosed with CLAI and GJL. The study compares these two procedures to assess differences in postoperative ankle stability and function over time. During the study, participants' ankle function will be evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) score at 3 months, 6 months, 1 year, and 2 years after surgery. Additional assessments include stress radiography measuring anterior displacement and talar tilt angle at 2 years and monitoring the rate of re-injury over the same period. The total study duration extends through these follow-up assessments to monitor outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of lateral ankle instability
  • Beighton score �3e=4 indicating generalized joint laxity
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • Acute or subacute ankle injury
  • Injury of the deltoid ligament
  • Lower extremity alignment greater than 5 degrees
  • Fractures in the lower extremity
  • Stage III or IV osteoarthritis
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and hospital stay

Participants undergo either the Modified Broström procedure with or without suture tape augmentation for chronic lateral ankle instability and receive immediate post-operative care.

1 surgery visit and immediate post-operative care

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored for recovery and outcomes following surgery, including clinical assessments and radiographic measures.

Follow-up visits at 3 months, 6 months, 1 year, and 2 years

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

D

Dong Jiang, MD

H

Haoxuan Liu, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Broström Repair for Chronic Lateral Ankle Instability? A Systematic Review.

Ulrike Wittig, Gloria Hohenberger, Martin Ornig...

https://pubmed.ncbi.nlm.nih.gov/34252562