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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

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ClinicalTrials.gov Identifier: NCT00364897
Recruitment Status : Withdrawn
First Posted : August 16, 2006
Last Update Posted : April 11, 2007
Sponsor:
Information provided by:

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 Phase
Primary ACL Tears Phase 2

Study Design

Study Type : Observational
Estimated Enrollment : 140 participants
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 the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364897


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

ClinicalTrials.gov Identifier: NCT00364897     History of Changes
Other Study ID Numbers: ACL001-HMO-CTIL
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: February 2007