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

Hadassah Medical Organization140 enrolled

Overview

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 .

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Primary ACL Tears

Eligibility

Sex: ALLMin age: 21 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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