Status:
WITHDRAWN
Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Primary ACL Tears
Eligibility:
All Genders
21-40 years
Brief Summary
Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing ...
Eligibility Criteria
Inclusion
- Males and females between ages 21 and 40 years.
- Primary ACL tears.
- Signed Informed consent.
- Availability during follow up period.
Exclusion
- Additional meniscal injury requiring suture.
- Articular cartilage injury requiring surgical management.
- Concomitant ligament injuries to the same knee requiring surgery.
- Bilateral ACL injury.
- Revision ACL surgery.
- Concurrent fractures of the lower limbs caused by the same accident.
- Post operative wound infection.
- • Post operative nerve injury
- Cardiovascular compromise.
- Professional sports people.
- Soldiers on active military service.
- Patients actively seeking compensation for injury.
- Patients on other research protocols.
- Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs.
- Non compliance. • Pregnancy
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00364897
Last Update
April 11 2007
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