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

Study Overview
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Brief Summary
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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?

Official Title
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Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Procedure: Computer-assisted surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>applying a patellar graft using conventional surgical technique. | |
| No Intervention: 2<br>applying a hamstring graft using conventional surgical technique. | |
| Experimental: 3<br>applying a patellar graft using a computer-assisted surgy technique. | Procedure: Computer-assisted surgery<br>* no description<br>|
| Experimental: 4<br>hamstring graft CAOS | Procedure: Computer-assisted surgery<br>* no description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome under investigation is knee laxity as reflected by graft tension. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL computer-assisted surgery graft