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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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00364897
Collaborator
(none)
140
Enrollment

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Official Title:
    Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years to 40 Years
      Sexes Eligible for Study:
      All
      Accepts 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

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Hadassah Medical Organization

      Investigators

      • Principal Investigator: Joseph Lowe, Dr., Hadassah Medical Organization

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00364897
      Other Study ID Numbers:
      • ACL001-HMO-CTIL
      First Posted:
      Aug 16, 2006
      Last Update Posted:
      Apr 11, 2007
      Last Verified:
      Feb 1, 2007
      Additional relevant MeSH terms:
      Anterior Cruciate Ligament Injuries

      Study Results

      No Results Posted as of Apr 11, 2007