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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230215
• Other study ID #: 105453
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2018

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. •

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Orthopaedic Foundation, Smith & Nephew, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Component Alignment	Using standard 3 foot hip-to-ankle radiographs to determine radiographic alignment of the implant components and mechanical axis of the limb.	1 year, 2 year
Other	Cost	Tracking time and instruments used per procedure and waste collected.	Intraoperatively
Primary	Evaluating the Change in Implant Fixation assessed using RSA imaging	Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.	2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
Secondary	Patient Outcomes including Satisfaction	Patient reported outcome measures provide important insight into how well total knee replacement performs from the patient's perspective. We will obtain patient surveys using four common, validated outcome measures: Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 Health Survey (SF-12), and University of California, Los Angeles (UCLA) Activity Score	Preoperatively, 1 year, 2 year