Trials / Completed
CompletedNCT00954330
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Finnish Defense Forces · Other Government
- Sex
- Male
- Age
- 19 Years – 25 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | lateral ligament surgery | . The disrupted FTA or/and FC and superficial retinacular structures were repaired by using absorbable sutures. 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. |
| 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. |
Timeline
- Start date
- 1991-02-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2009-08-07
- Last updated
- 2009-08-07
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT00954330. Inclusion in this directory is not an endorsement.