Clinical trial NCT00300300: Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques
Official title: Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: ACL computer-assisted surgery graft
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2006-03-08
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: The main outcome under investigation is knee laxity as reflected by graft tension.
timeFrame: 2 years
Secondary outcomes:
measure: Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.
timeFrame: 2 years
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University (faculty)
name: Davide Bardana, MD
role: PRINCIPAL_INVESTIGATOR
References: