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Sponsored by: |
Finnish Defense Forces |
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Information provided by: | Finnish Defense Forces |
ClinicalTrials.gov Identifier: | NCT00954330 |
The aim of this prospective randomized controlled trial was to compare the effectiveness of surgical and conservative treatment in acute lateral ligament injury of ankle. The more detailed aims were to assess the function, physical activity level, re-injuries, objective stability and radiographic changes seen by magnetic resonance imaging in patients randomized to surgery or to functional treatment after a mean of 14 years follow-up.
Condition | Intervention |
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Ankle Injury |
Procedure: lateral ligament surgery Device: functional treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control |
Official Title: | Surgical Versus Functional Treatment for Acute Ruptures of the Lateral Ligament Complex of the Ankle in Young Males - A Randomized Controlled Trial With a Mean of 14 Years Follow-up |
Enrollment: | 51 |
Study Start Date: | February 1991 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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surgery: Experimental
All twenty-five patients underwent ligament repair, where the ruptured ends of the FTA (in 11 cases) or FTA and FC (in 14 cases) ligaments were rejoined by using absorbable sutures. A supine position and a tourniquet were used. A curvilinear skin incision of 5-10 cm was made; the retinacular structures were incised and the hematoma was removed.
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Procedure: lateral ligament surgery
In case of avulsion from the bone, the ligament was reapproximated with the use of sutures that were passed through 2.0 millimeter drill-holes in the bone. |
functional treatment: Active Comparator
Twenty-six patients randomized to the functional treatment received a functional light-weight orthotic device (Air-Cast ankle brace, Summit, New Jersey) for 3 weeks. Full weight bearing was allowed. The ankle brace allowed dorsi- and plantarflexion but it restricted inversion and eversion of the ankle
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Device: functional treatment
Twenty-six patients randomized to the functional treatment received a functional light-weight orthotic device (Air-Cast ankle brace, Summit, New Jersey) for 3 weeks. Full weight bearing was allowed. The ankle brace allowed dorsi- and plantarflexion but it restricted inversion and eversion of the ankle.
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Ages Eligible for Study: | 19 Years to 25 Years |
Genders Eligible for Study: | Male |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 555555 |
Study First Received: | August 6, 2009 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00954330 History of Changes |
Health Authority: | Finland: Ethics Committee |
rct, intervention, surgery, lateral ligament injury of the ankle REturn to pre-injury level |
Ankle Injuries Wounds and Injuries Disorders of Environmental Origin Rupture Leg Injuries |
Ankle Injuries Wounds and Injuries Disorders of Environmental Origin Leg Injuries |