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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00364897
First received: August 15, 2006
Last updated: April 10, 2007
Last verified: February 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 140
  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364897

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Joseph Lowe, Dr. Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364897     History of Changes
Other Study ID Numbers: ACL001-HMO-CTIL
Study First Received: August 15, 2006
Last Updated: April 10, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on June 18, 2013