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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00300300
Other study ID # Bard0105
Secondary ID
Status Terminated
Phase Phase 4
First received March 6, 2006
Last updated September 9, 2015
Start date September 2009
Est. completion date January 2029

Study information

Verified date September 2015
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Terminated
Enrollment 125
Est. completion date January 2029
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction

Intervention

Procedure:
Computer-assisted surgery
no description

Locations

Country Name City State
Canada Kingston General Hospital Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The main outcome under investigation is knee laxity as reflected by graft tension. 2 years No
Secondary Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion. 2 years No
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