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

NCT ID: NCT00954330

Last Updated: 2009-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-02-28
• Study Completion Date: 2008-12-31

Brief 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

Ankle Injury

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

surgery

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.

Group Type: EXPERIMENTAL

lateral ligament surgery

Intervention Type: PROCEDURE

. 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.

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

Group Type: ACTIVE_COMPARATOR

functional treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The positive findings for a lateral ligament injury included a clinically unstable ankle and a radiological talar tilt >6 degrees or ADS >5 mm compared with the uninjured opposite ankle.

Exclusion Criteria

• In addition, patients were excluded from our study if they had previously undergone surgery of the ankle region.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Finnish Defense Forces

OTHER_GOV

Sponsor Role: lead

Locations

Central military hospital

Helsinki, , Finland

Countries

Finland

Other Identifiers

555555

Identifier Type: -

Identifier Source: org_study_id