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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00300300
• Other study ID #: Bard0105
• 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