Surgery for chronic ankle instability using an internal brace
Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.
NA · St. Anna Ziekenhuis, Geldrop, Netherlands · NCT03472404
This study is testing if using an internal brace during ankle surgery helps people with chronic ankle instability recover faster and feel better compared to standard surgery methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | St. Anna Ziekenhuis, Geldrop, Netherlands (other) |
| Locations | 3 sites (Apeldoorn and 2 other locations) |
| Trial ID | NCT03472404 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using an internal brace during lateral ligament ankle surgery for patients with chronic ankle instability. Participants will be divided into two groups: one receiving the standard Brostrom-Gould reconstruction with a traditional rehabilitation protocol, and the other receiving the same surgery augmented with an internal brace followed by an accelerated rehabilitation program. The goal is to determine if the internal brace allows for earlier rehabilitation and improved outcomes compared to standard methods. This approach aims to reduce recovery time and enhance ankle function post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic lateral ankle instability who have not responded to conservative treatment and have specific anatomical criteria.
Not a fit: Patients with conditions that do not involve isolated anterior talofibular ligament damage or those who have not experienced chronic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to faster recovery and improved function for patients suffering from chronic ankle instability.
How similar studies have performed: While the use of internal bracing in surgical procedures is gaining interest, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients diagnosed with chronic lateral ankle instability (multiple ankle inversion trauma within 12 months and symptoms present \>1 year). Lateral ankle instability is present if the patient complains of giving way of the ankle and has positive signs of ankle instability during physical exam (talar tilt score of \>15 degrees compared to contralateral ankle or anterior drawer test score of \>10mm compared to the contralateral ankle. * Conservative therapy has failed. * Normal foot and ankle anatomy as determined by orthopedic surgeon. * Patients in whom their ankle symptoms interfere with their physical activities. * Patients with isolated anterior talofibular ligament which is indicated for repair using the Brostrom-Gould technique. * BMI ≤30 * Patients who are able and willing to undergo ankle surgery. * Patients who are able and willing to comply with the rehabilitation protocol in any of the study physiotherapy centers. * Patients who are able and willing to return for follow-up evaluations. * Patients with sufficient understanding of the Dutch language. Exclusion Criteria: * Patients who need concomitant ankle surgery (i.e. Calcaneofibular ligament reconstruction, peroneus tendon repair, arthroscopy of the ankle, etc). * Patients with comorbidities, including musculoskeletal injuries or diseases in other joints than the affected ankle which limits their physical activity. * Ankle instability due to abnormal foot and ankle anatomy. * No objective or subjective ankle instability. * Previous ankle surgery. * Patients in which the contralateral ankle also shows lateral ankle instability.
Where this trial is running
Apeldoorn and 2 other locations
- Gelre Ziekenhuis — Apeldoorn, Netherlands (RECRUITING)
- Medinova — Breda, Netherlands (RECRUITING)
- St Anna hospital — Geldrop, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Walter van der Weegen, Dr. — St. Anna Hospital
- Study coordinator: Walter van der Weegen, Dr.
- Email: w.vander.weegen@st-anna.nl
- Phone: +31 (0) 40 2864 280
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.
Conditions: Ankle Sprains, Talofibular, Sprain