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Use of Graft Tensioner Device in ACL (Knee) Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221273
First Posted: September 22, 2005
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Enrollment: 130
Study Start Date: December 2010
Study Completion Date: May 18, 2012
Primary Completion Date: May 18, 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Torn ACL amenable to surgery

Exclusion Criteria:

  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): NCT00221273


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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00221273     History of Changes
Other Study ID Numbers: H05-70302
First Submitted: September 18, 2005
First Posted: September 22, 2005
Last Update Posted: March 3, 2017
Last Verified: March 2017