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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

This study has been withdrawn prior to enrollment.
Information provided by:
Hadassah Medical Organization Identifier:
First received: August 15, 2006
Last updated: April 10, 2007
Last verified: February 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 .

Condition Phase
Primary ACL Tears Phase 2

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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 140

Ages Eligible for Study:   21 Years to 40 Years   (Adult)
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
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Please refer to this study by its identifier: NCT00364897

Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Joseph Lowe, Dr. Hadassah Medical Organization
  More Information Identifier: NCT00364897     History of Changes
Other Study ID Numbers: ACL001-HMO-CTIL
Study First Received: August 15, 2006
Last Updated: April 10, 2007 processed this record on August 17, 2017