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

This study has suspended participant recruitment.
(Study temporarily suspended until funding can be secured.)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00300300
First received: March 6, 2006
Last updated: April 28, 2009
Last verified: April 2009

March 6, 2006
April 28, 2009
September 2009
September 2011   (final data collection date for primary outcome measure)
The main outcome under investigation is knee laxity as reflected by graft tension. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The main outcome under investigation is knee laxity as reflected by graft tension.
Complete list of historical versions of study NCT00300300 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.
Not Provided
Not Provided
 
Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques
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?

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Anterior Cruciate Ligament Reconstruction
Procedure: Computer-assisted surgery
no description
  • No Intervention: 1
    patellar graft conventional
  • No Intervention: 2
    hamstring graft conventional
  • Experimental: 3
    patellar graft CAOS
    Intervention: Procedure: Computer-assisted surgery
  • Experimental: 4
    hamstring graft CAOS
    Intervention: Procedure: Computer-assisted surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
125
September 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00300300
Bard0105
No
Dr. Davide Bardana, Queen's University
Queen's University
Not Provided
Principal Investigator: Davide Bardana, MD Queen's University (faculty)
Queen's University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP