Dynamic intraligamentary stabilization versus primary tendinoplasty in acute lesion of the anterior cruciate ligament: a prospective randomized trial.
Not Applicable
- Conditions
- S83.53
- Registration Number
- DRKS00015466
- Lead Sponsor
- niversitätsklinikum Münster, Klinik für Unfall-, Hand- und Wiederherstellungschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
first time lesion of the anterior cruciate ligament; signed informed consent; willingness to participate in the follow up schedule; operation in the first 21 days after injury.
Exclusion Criteria
lack of compliance; lack of willingness to participate in the follow up schedule; dramatic, traumatic or degenerative lesions of meniscus or cartilage; earlier tendon graft harvesting in the injured leg; relevant medication; pregnancy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Follow up one year postoperatively with assessment of subjective clinical scores (Tegner, Lysholm, IKDC subjective), visual analogue scale of pain and patient satisfaction, objective clinical assessment of range of motion, anterior translation (Rolimeter-Lachman) and pivot shift test, reoperation and complications.
- Secondary Outcome Measures
Name Time Method In order to assess longterm results follow ups will be repeated after 2, 5 and 10 years including the assessment of subjective clinical scores (Tegner, Lysholm, IKDC subjective), visual analogue scale of pain and patient satisfaction, objective clinical assessment of range of motion, anterior translation (Rolimeter-Lachman) and pivot shift test, reoperation and complications. Optional assessment of MRI scans.