Clinical Trials Directory

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

TypeNameDescription
PROCEDURElateral 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.
DEVICEfunctional treatmentTwenty-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.