Use of Graft Tensioner Device in ACL (Knee) Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of British Columbia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00221273
First received: September 18, 2005
Last updated: April 26, 2011
Last verified: April 2011
  Purpose

Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.


Condition Intervention
Torn Anterior Cruciate Ligament (Knee)
Procedure: ACL surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning in Hamstring ACL Reconstruction

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Endpoints Measured at 6, 12, 18 months post op compared to pre-op [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: ACL surgery
    Unspecified
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Torn ACL amenable to surgery

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221273

Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: J Leith, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. J.M. Leith, University of British Columbia
ClinicalTrials.gov Identifier: NCT00221273     History of Changes
Other Study ID Numbers: C05-0302
Study First Received: September 18, 2005
Last Updated: April 26, 2011
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 23, 2014