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

NCT00300300 | Terminated Phase 4

• 1 other identifier: Bard0105
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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

Keywords

ACL computer-assisted surgery graft

Outcome Measures

Primary Outcomes (1)

• The main outcome under investigation is knee laxity as reflected by graft tension.

  2 years

Secondary Outcomes (1)

• Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.

  2 years

Study Arms (4)

1

NO INTERVENTION

applying a patellar graft using conventional surgical technique.

2

NO INTERVENTION

applying a hamstring graft using conventional surgical technique.

3

EXPERIMENTAL

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

Procedure: Computer-assisted surgery

4

EXPERIMENTAL

hamstring graft CAOS

Procedure: Computer-assisted surgery

Interventions

Computer-assisted surgery PROCEDURE

no description

3; 4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of a chronic unilateral rupture of the anterior cruciate ligament
• Aged 18-40

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Interventions

Surgery, Computer-Assisted

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Davide Bardana, MD

  Queen's University (faculty)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2006
• First Posted: March 8, 2006
• Study Start: September 1, 2009
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

CA (1)