Back to resultsSurgical 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
Primary Purpose
Ankle Injury
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
lateral ligament surgery
functional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injury focused on measuring rct, intervention, surgery, lateral ligament injury of the ankle, REturn to pre-injury level
Eligibility 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.
Sites / Locations
- Central military hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
surgery
functional treatment
Arm Description
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.
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
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00954330
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 1991 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Finnish Defense Forces
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injury
Keywords
rct, intervention, surgery, lateral ligament injury of the ankle, REturn to pre-injury level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
functional treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
lateral ligament surgery
Intervention Description
. 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.
Intervention Type
Device
Intervention Name(s)
functional treatment
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Eligibility 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.
Facility Information:
Facility Name
Central military hospital
City
Helsinki
ZIP/Postal Code
00301
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
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
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