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

November 7, 2018 updated by: Douglas Naudie, Lawson Health Research Institute
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.

Study Overview

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. •

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A5A5
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient-Specific Instrumentation
Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation
The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.
Other Names:
  • Visionaire Patient Specific Instrumentation
No Intervention: Traditional Instrumentation
Patients to have a total knee replacement surgery done using traditional instrumentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the Change in Implant Fixation assessed using RSA imaging
Time Frame: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Outcomes including Satisfaction
Time Frame: Preoperatively, 1 year, 2 year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Component Alignment
Time Frame: 1 year, 2 year
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
Cost
Time Frame: Intraoperatively
Tracking time and instruments used per procedure and waste collected.
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 105453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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