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

Queen's University

Status and phase: Terminated; Phase 4

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Procedure: Computer-assisted surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00300300

Bard0105

Details and patient eligibility

About

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?

Enrollment: 125 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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125 participants in 4 patient groups

1

No Intervention group

Description:

applying a patellar graft using conventional surgical technique.

2

No Intervention group

Description:

applying a hamstring graft using conventional surgical technique.

3

Experimental group

Description:

applying a patellar graft using a computer-assisted surgy technique.

Treatment:

Procedure: Computer-assisted surgery

4

Experimental group

Description:

hamstring graft CAOS

Treatment:

Procedure: Computer-assisted surgery