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

Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00364897
Enrollment
140
Registered
2006-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2007-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary ACL Tears

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 .

Interventions

None listed

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026