Status:
UNKNOWN
inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG
Lead Sponsor:
Walter van der Weegen
Collaborating Sponsors:
Medinova Clinics
Gelre Hospitals
Conditions:
Ankle Sprains
Talofibular; Sprain (Strain)
Eligibility:
All Genders
16-60 years
Phase:
NA
Brief 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 ...
Detailed Description
Ankle inversion trauma often leads to chronic ankle instability which can severely limit the patient during daily activities, including work and sports. When conservative treatment fails, surgical tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03472404
Start Date
October 1 2018
End Date
December 31 2024
Last Update
June 5 2023
Active Locations (3)
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1
Gelre Ziekenhuis
Apeldoorn, Netherlands
2
Medinova
Breda, Netherlands
3
St Anna hospital
Geldrop, Netherlands, 5664EH