Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty

NCT ID: NCT02230215

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-08-31

Brief Summary

This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.

Detailed Description

This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.

All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith & Nephew).

Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.

• Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.

During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.

RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the Robart's Research Institute after their standard of care visit with orthopaedic surgeon.

Model based RSA software used to measure motion of implant components relative to bone markers.

All patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patient-Specific Instrumentation

Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation

Group Type: EXPERIMENTAL

Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation

Intervention Type: DEVICE

The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.

Traditional Instrumentation

Patients to have a total knee replacement surgery done using traditional instrumentation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation

The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.

Intervention Type: DEVICE

Other Intervention Names

Visionaire Patient Specific Instrumentation

Eligibility Criteria

Inclusion Criteria

• Undergoing primary total knee replacement surgery
• No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
• BMI < 40
• Study patients should live within 100 km of our facility to ensure availability for follow-up

Exclusion Criteria

• Pregnancy or considering pregnancy
• BMI > 40
• Unable to undergo MRI screening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Orthopaedic Foundation

OTHER

Sponsor Role: collaborator

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Douglas Naudie

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Naudie, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

University Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

105453

Identifier Type: -

Identifier Source: org_study_id