Comparing two surgical methods for chronic ankle instability
The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
This study is testing which of two surgical methods works better for people with chronic ankle instability to help them recover and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05196906 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the clinical outcomes of the modified Broström operation and anatomical reconstruction for treating chronic lateral ankle instability (CLAI) and generalized joint laxity (GJL). It is a prospective cohort study that will assess primary outcomes using the Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. Secondary outcomes include measuring anterior displacement and talar tilt angle in stress radiography, as well as the rate of re-injury. The goal is to determine which surgical method yields better results for patients with these conditions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 60 with a clinical diagnosis of lateral ankle pain and instability and a Beighton score of 4 or higher.
Not a fit: Patients with acute or subacute ankle injuries, significant lower extremity alignment issues, or advanced osteoarthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective surgical approach for patients suffering from chronic ankle instability and generalized joint laxity.
How similar studies have performed: While the modified Broström operation is commonly used, the comparative effectiveness of these two surgical methods in this specific patient population has not been extensively studied, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years Exclusion Criteria: Patients with an acute or subacute ankle injury (within 3 months) 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
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Dong Jiang, MD — Peking University Third Hosptial
- Study coordinator: Dong Jiang, MD
- Email: bysyjiangdong@126.com
- Phone: 13811280948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.