Use of Graft Tensioner Device in ACL (Knee) Repair

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. Identifier: NCT00221273
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
University of British Columbia

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

Condition or disease Intervention/treatment Phase
Torn Anterior Cruciate Ligament (Knee) Procedure: ACL surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : May 18, 2012
Actual Study Completion Date : May 18, 2012

Primary Outcome Measures :
  1. Endpoints Measured at 6, 12, 18 months post op compared to pre-op

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

Torn ACL amenable to surgery

Exclusion Criteria:

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 identifier (NCT number): NCT00221273

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

Responsible Party: University of British Columbia Identifier: NCT00221273     History of Changes
Other Study ID Numbers: H05-70302
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017