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

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.
ClinicalTrials.gov Identifier: NCT00300300
Recruitment Status : Terminated (Study temporarily suspended until funding can be secured.)
First Posted : March 8, 2006
Last Update Posted : September 10, 2015
Information provided by (Responsible Party):
Dr. David Bardana, Queen's University

Brief Summary:
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 or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Procedure: Computer-assisted surgery Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.
Study Start Date : September 2009
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
applying a patellar graft using conventional surgical technique.
No Intervention: 2
applying a hamstring graft using conventional surgical technique.
Experimental: 3
applying a patellar graft using a computer-assisted surgy technique.
Procedure: Computer-assisted surgery
no description
Experimental: 4
hamstring graft CAOS
Procedure: Computer-assisted surgery
no description

Primary Outcome Measures :
  1. The main outcome under investigation is knee laxity as reflected by graft tension. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT00300300

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

Responsible Party: Dr. David Bardana, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00300300     History of Changes
Other Study ID Numbers: Bard0105
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015

Keywords provided by Dr. David Bardana, Queen's University:
ACL computer-assisted surgery graft