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Sponsored by: |
Queen's University |
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Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00300300 |
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 |
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Anterior Cruciate Ligament Reconstruction |
Procedure: Computer-assisted surgery |
Phase IV |
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. |
Estimated Enrollment: | 125 |
Estimated Study Completion Date: | May 2010 |
Arms | Assigned Interventions |
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1: No Intervention
patellar graft conventional
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2: No Intervention
hamstring graft conventional
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3: Experimental
patellar graft CAOS
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Procedure: Computer-assisted surgery
no description
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4: Experimental
hamstring graft CAOS
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Procedure: Computer-assisted surgery
no description
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
ACL computer-assisted surgery graft |