Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- The main outcome under investigation is knee laxity as reflected by graft tension. [2 years]
Secondary Outcome Measures
- Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion. [2 years]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
Sponsors and Collaborators
- Queen's University
Investigators
- Principal Investigator: Davide Bardana, MD, Queen's University (faculty)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Bard0105