Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath

Withdrawn

• Conditions: Primary ACL Tears

• Registration Number: NCT00364897
• Lead Sponsor: Hadassah Medical Organization

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 double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-15
• Study First Submitted QC: 2006-08-15
• Study First Posted: 2006-08-16
• Status Verified: 2007-02
• Last Update Submitted: 2007-04-10
• Last Update Posted: 2007-04-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified