Actively Recruiting

Age: 18Years - 60Years
All Genders
ID05698446

Comparison of Modified Brostr6m Repair + Suture Tape and Anatomic Reconstruction for CLAI in Generalized Joint Laxity Cases: A Prospective Cohort Study

Led by Peking University Third Hospital · Updated on 2025-04-11

114

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Generalized joint laxity (GJL) may increase the risk of repeated ankle instability after surgery for chronic lateral ankle instability (CLAI). Researchers are comparing three surgical approaches to see which provides better strength and stability in patients with GJL and CLAI. These approaches include modified Brostr6m repair (MBR) with suture tape augmentation, anatomic reconstruction, and open modified Brostr6m-Gould surgery. The study aims to understand differences in outcomes and potential complications such as suture tape rejection or trauma from surgery. The study observes patients who choose one of the three surgeries: MBR with suture tape augmentation, anatomic reconstruction, or open modified Brostr6m-Gould surgery. Each procedure is performed as a surgical treatment to address ankle instability. Patients are grouped based on the surgery they accept. The researchers will monitor and compare the results of these different operations over time. Participants will be followed for at least two years after surgery. The main outcomes measured are the Karlsson-Peterson score to evaluate ankle function at one and two years after the operation. Secondary outcomes include X-ray measures of ankle stability, such as anterior displacement and talar tilt angle, taken two years after surgery. The study is conducted by Peking University Third Hospital and includes adult patients aged 18 to 60 years with clinical signs of ankle instability and GJL.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of lateral ankle pain and instability
  • Beighton score of 4 or higher
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • Acute or subacute ankle injury within 3 months
  • Injury of the deltoid ligament
  • Lower extremity alignment greater than 5 degrees
  • Fractures of the lower extremity
  • Stage III or IV osteoarthritis
  • Patients who refused to participate in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Single surgical event

Participants undergo one of three surgical procedures: Modified Broström + Suture tape augmentation operation, Anatomic reconstruction operation, or Open Modified Broström-Gould surgery for chronic lateral ankle instability.

1 surgical procedure visit

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored for post-surgery recovery and outcomes including ankle stability and function.

Visits at 1 year and 2 years post-surgery

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

Actively Recruiting

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Research Team

D

Dong Jiang, MD

A

Anhong Wang, 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

3

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Published Research Related To This Trial

Generalized Joint Laxity in Orthopaedic Patients: Clinical Manifestations, Radiographic Correlates, and Management.

Hayley A Sacks, Pooja Prabhakar, Lauren E Wessel...

https://pubmed.ncbi.nlm.nih.gov/30893238

A randomized comparison between lateral ligaments augmentation using suture-tape and modified Broström repair in young female patients with chronic ankle instability.

Byung-Ki Cho, Ji-Kang Park, Seung-Myung Choi...

https://pubmed.ncbi.nlm.nih.gov/29409289