Comparing two surgical methods for ankle instability
Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study
This study is testing whether adding suture tape to a common ankle surgery helps people with joint laxity recover better from ankle instability.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06897293 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the outcomes of the modified Broström procedure (MBR) for chronic lateral ankle instability (CLAI) with and without suture tape augmentation in patients with generalized joint laxity (GJL). The study will assess the effectiveness of the suture tape in providing additional strength and stability to the ankle post-surgery. Participants will be monitored for postoperative recurrent instability to determine the benefits of the augmentation. The study focuses on individuals aged 18 to 60 who meet specific clinical criteria for ankle instability.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 60 with a clinical diagnosis of lateral ankle instability and a Beighton score of 4 or higher.
Not a fit: Patients with acute 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 lead to improved surgical outcomes and reduced recurrence of ankle instability for patients with GJL.
How similar studies have performed: While the approach of using suture tape augmentation is being explored, the specific outcomes of this combination have not been extensively studied, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- 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.