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Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques
This study has been suspended.
Sponsored by: Queen's University
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00300300
  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 IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment
Official Title: Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-Assisted Versus a Conventional Surgical Technique.

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
Estimated Study Completion Date: May 2010
Arms Assigned Interventions
1: No Intervention
patellar graft conventional
2: No Intervention
hamstring graft conventional
3: Experimental
patellar graft CAOS
Procedure: Computer-assisted surgery
no description
4: Experimental
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

Responsible Party: Acting manager ( Leone Ploeg )
Study ID Numbers: Bard0105
Study First Received: March 6, 2006
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00300300  
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on January 15, 2009