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

NCT02230215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Canadian Orthopaedic Foundation

    collaborator OTHER

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Douglas Naudie, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02230215 on ClinicalTrials.gov