inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG (NCT03472404) | Clinical Trial Compass
UnknownNot Applicable
inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG
Netherlands42 participantsStarted 2018-10-01
Plain-language summary
This study evaluates the effect of internal bracing in lateral ligament ankle surgery. Half of the patients will receive the standard Brostrom-Gould reconstruction followed by a standard revalidation protocol including 6 weeks of immobilisation, while the other half of the patients will receive the same operation augmented with internal brace followed by an accelerated rehabilitation protocol.
Who can participate
Age range16 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months
Timeframe: pre-operative, post-operative at 12 months