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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00954330
Other study ID # 555555
Secondary ID
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
Accepts healthy volunteers
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


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
See also
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Terminated NCT02643524 - Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use N/A