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

NCT ID: NCT00300300

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2029-01-31

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?

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

applying a patellar graft using conventional surgical technique.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

applying a hamstring graft using conventional surgical technique.

Group Type: NO_INTERVENTION

No interventions assigned to this group

3

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

Group Type: EXPERIMENTAL

Computer-assisted surgery

Intervention Type: PROCEDURE

no description

4

hamstring graft CAOS

Group Type: EXPERIMENTAL

Computer-assisted surgery

Intervention Type: PROCEDURE

no description

Interventions

Computer-assisted surgery

no description

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. David Bardana

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davide Bardana, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University (faculty)

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

Bard0105

Identifier Type: -

Identifier Source: org_study_id