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

NCT00954330 | Completed

• 1 other identifier: 555555
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

rct, intervention, surgery, lateral ligament injury of the ankle; REturn to pre-injury level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Procedure: lateral ligament surgery

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

Device: functional treatment

Interventions

lateral ligament surgery 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.

surgery

functional treatment 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.

functional treatment

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Finnish Defense Forces: lead

Study Sites (1)

Central military hospital

Helsinki, 00301, Finland

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: February 1, 1991
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 7, 2009

Record last verified: 2009-08

Locations

FI (1)