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

Ankle Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954330
• Other study ID #: 555555
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: August 6, 2009
• Start date: February 1991
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Finnish Defense Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Gender: Male
• Age group: 19 Years to 25 Years

Eligibility

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

Allocation: Randomized, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injury

Intervention

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.

Locations

Country	Name	City	State
Finland	Central military hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Finnish Defense Forces

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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