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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.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00300300
Enrollment
125
Registered
2006-03-08
Start date
2009-09-30
Completion date
2029-01-31
Last updated
2015-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACL computer-assisted surgery graft

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?

Interventions

no description

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The main outcome under investigation is knee laxity as reflected by graft tension.2 years

Secondary

MeasureTime frame
Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026