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

This study has been completed.
Sponsor:
Information provided by:
Finnish Defense Forces
ClinicalTrials.gov Identifier:
NCT00954330
First received: August 6, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Ankle Injury
Procedure: lateral ligament surgery
Device: functional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Finnish Defense Forces:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 51
Study Start Date: February 1991
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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
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.

  Eligibility

Ages Eligible for Study:   19 Years to 25 Years
Genders Eligible for Study:   Male
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954330

Locations
Finland
Central military hospital
Helsinki, Finland, 00301
Sponsors and Collaborators
Finnish Defense Forces
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00954330     History of Changes
Other Study ID Numbers: 555555
Study First Received: August 6, 2009
Last Updated: August 6, 2009
Health Authority: Finland: Ethics Committee

Keywords provided by Finnish Defense Forces:
rct, intervention, surgery, lateral ligament injury of the ankle
REturn to pre-injury level

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014