Use of Graft Tensioner Device in ACL (Knee) Repair

This study is not yet open for participant recruitment.

Verified by University of British Columbia, September 2008

First Received: September 18, 2005 Last Updated: September 8, 2008 History of Changes

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00221273

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

MedlinePlus related topics: Surgery

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
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:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Unspecified

Eligibility

Criteria

Inclusion Criteria: Torn ACL amenable to surgery Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Cheryl Davies, RN

604-875-5886

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

J Leith, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. J.M. Leith )
Study ID Numbers:	C05-0302
Study First Received:	September 18, 2005
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00221273 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on May 06, 2009