Primary ACL Tears Clinical Trial
Official title:
Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction
| NCT number | NCT00364897 |
| Other study ID # | ACL001-HMO-CTIL |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 2 |
| First received | August 15, 2006 |
| Last updated | April 10, 2007 |
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 double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .
| Status | Withdrawn |
| Enrollment | 140 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Males and females between ages 21 and 40 years. - Primary ACL tears. - Signed Informed consent. - Availability during follow up period. Exclusion Criteria: - 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 |
Observational Model: Defined Population, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |