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Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques

This study has suspended participant recruitment.
(Study temporarily suspended until funding can be secured.)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00300300
First received: March 6, 2006
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  Purpose

ACL reconstruction in the Division of Orthopaedic surgery at Queen's is currently being performed arthroscopically assisted. The resultant function of the reconstructed ligament is greatly influenced by the placement of the transosseous tunnels, which are tunnels in the bones through which the grafts pass. Presently the placement of the tunnels is being judged from arthroscopically identified anatomical landmarks within the joint. The result is incidence rates of misplaced tunnels as high as 40%. Computer assisted tunnel placement would aid in the correction and reproducibility of anatomic tunnel placement. The objective of this study is to conduct a prospective, randomized trial comparing clinical and radiographic outcomes in subjects who receive either a patella or hamstring tendon graft to reconstruct a chronic tear of the anterior cruciate ligament. All subjects will be further randomized into a computer-assisted or a conventional arthroscopic surgical group to allow investigators to compare the precision and accuracy of tunnel placement between these surgical approaches. The main question under investigation is: does the increased accuracy of computer-assisted surgery make a clinical difference to the laxity of the reconstructed knee, and is the laxity further influenced by the type of tendon graft received?


Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction
 Procedure: Computer-assisted surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-Assisted Versus a Conventional Surgical Technique.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • The main outcome under investigation is knee laxity as reflected by graft tension. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
patellar graft conventional
No Intervention: 2
hamstring graft conventional
Experimental: 3
patellar graft CAOS
 Procedure: Computer-assisted surgery
no description
Experimental: 4
hamstring graft CAOS
 Procedure: Computer-assisted surgery
no description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of a chronic unilateral rupture of the anterior cruciate ligament
  • Aged 18-40

Exclusion Criteria:

  • Acute injury of the ACL (interval between the injury and operation is < 30 days).
  • Other ligament tears and/or operation on the operative knee (with the exception of a previous meniscectomy).
  • Injury of the contralateral knee.
  • Degenerative changes of the articular cartilage (grade III or IV changes according to the Outerbrige classification system)
  • Complaints of patellofemoral symptoms
  • Patient is pregnant
  • Inability to complete 2-year follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300300

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Davide Bardana, MD Queen's University (faculty)
  More Information

No publications provided

Responsible Party: Dr. Davide Bardana, Queen's University
ClinicalTrials.gov Identifier: NCT00300300     History of Changes
Other Study ID Numbers: Bard0105
Study First Received: March 6, 2006
Last Updated: April 28, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
ACL computer-assisted surgery graft

ClinicalTrials.gov processed this record on May 22, 2013