Actively Recruiting

Age: 18Years - 60Years
All Genders
ID05196906

Clinical Outcomes Comparing Modified Broström and Anatomic Reconstruction Operations in Chronic Lateral Ankle Instability and Generalized Joint Laxity

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

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical outcomes of two surgical treatments, the modified Broström operation and anatomical reconstruction, for people with chronic lateral ankle instability (CLAI) and generalized joint laxity (GJL). This prospective cohort study aims to compare these two operations to determine differences in re-injury rates and functional outcomes, addressing concerns about higher re-injury with the modified Broström operation in patients with GJL. Participants will undergo either the modified Broström operation or anatomical reconstruction as their treatment. The study groups include patients receiving one of these two procedures to treat CLAI and GJL. The primary outcomes measured are functional scores such as the Karlsson score, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM). Secondary outcomes include radiographic assessments like anterior displacement and talar tilt angle, as well as monitoring re-injury rates. Throughout the study, participants will be assessed over a period of up to two years after surgery. Postoperative evaluations will include clinical scoring at one and two years and radiographic measurements at two years. Researchers will closely monitor ankle stability and function using these scores and imaging tests to understand the effectiveness and safety of each surgical option. The total duration of participation extends to at least two years following the operation.

CONDITIONS

Brief Title

The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL

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 indicating generalized joint laxity
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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 - Not specified

Participants undergo either a modified Broström operation or an anatomic reconstruction operation to treat chronic lateral ankle instability and generalized joint laxity.

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored to assess clinical outcomes, including Karlsson scores and radiographic measures, over the long term.

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

Actively Recruiting

Loading map...

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

2

Similar Trials

A Mobile Recovery Guidance App for Children and Young Adults...

Ankle Sprains

Actively Recruiting

1 location

Addressing Neuromuscular Deficits for Improved Outcomes in A...

Ankle Sprains

Actively Recruiting

2 locations

Arthroscopic Versus Open Brostrom for Ankle Instability: a R...

Ankle Sprains

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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

Generalized Ligamentous Laxity Is an Independent Predictor of Poor Outcomes After the Modified Broström Procedure for Chronic Lateral Ankle Instability.

Kwang Hwan Park, Jin Woo Lee, Jae Wan Suh...

https://pubmed.ncbi.nlm.nih.gov/27480980