Skip to main content
OpenTrials
Completed

NCT Number: NCT02230215

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

London, Ontario, N6A5A5, Canada

About this study

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. •

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

  2. Cost

    Time frame: Intraoperatively

    Tracking time and instruments used per procedure and waste collected.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Canadian Orthopaedic Foundation
  • Smith & Nephew, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2014
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.