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

Not Applicable

Completed

• Conditions: Ankle Injury
• Interventions: Procedure: lateral ligament surgery; Device: functional treatment

• Registration Number: NCT00954330
• Lead Sponsor: Finnish Defense Forces

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-08
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Last Update Submitted: 2009-08-06
• Study First Posted: 2009-08-07
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

• The inclusion criteria included positive stress radiographs (in all cases) and arthrography 15 (5 cases) proven fibulotalar anterior (FTA) and fibulocalcanear (FC) ligament injury.
• 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

• The exclusion criteria for the study were diabetes, inflammatory arthritis, previous severe trauma, pre-existing instability of joints.
• In addition, patients were excluded from our study if they had previously undergone surgery of the ankle region.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery	lateral ligament 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.
functional treatment	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

Primary Outcome Measures

Name	Time	Method
The main outcome measure in the present study was a validated ankle injury scoring scale, A Performance Test Protocol and Scoring Scale for the Evaluation of Ankle Injuries.

Secondary Outcome Measures

Name	Time	Method
Return to pre-injury level in physical activity, re-injuries of the same ankle, visits to physician due to the same ankle, range of joint motion, subjective satisfaction and complications were measured

Trial Locations

Locations (1)

Central military hospital; 🇫🇮 Helsinki, Finland