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

September 9, 2015 updated by: Dr. David Bardana, Queen's University

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

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?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Davide Bardana, MD, Queen's University (faculty)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

January 1, 2028

Study Completion (Anticipated)

January 1, 2029

Study Registration Dates

First Submitted

March 6, 2006

First Submitted That Met QC Criteria

March 6, 2006

First Posted (Estimate)

March 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bard0105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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