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Use of Graft Tensioner Device in ACL (Knee) Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00221273
First received: September 18, 2005
Last updated: March 1, 2017
Last verified: March 2017
  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: 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 [ Time Frame: Unspecified ]

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)
Intervention Details:
    Procedure: ACL surgery
    Unspecified
  Eligibility

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
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, see Learn About Clinical Studies.

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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00221273     History of Changes
Other Study ID Numbers: H05-70302
Study First Received: September 18, 2005
Last Updated: March 1, 2017

ClinicalTrials.gov processed this record on June 23, 2017