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RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

NCT03554720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-17

No results posted yet for this study

Summary

The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.

Conditions

Interventions

DEVICE

ATTUNE PS Knee

The ATTUNE PS Knee is the standard implants.

DEVICE

ATTUNE S+ PS Knee

The ATTUNE S+ PS Knee is the enhanced fixation.

Sponsors & Collaborators

  • Orthopaedic Innovation Centre

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • Canadian Radiostereometric Analysis Network

    lead OTHER

Principal Investigators

  • Thomas Turgeon, MD MPH FRCSC · University of Manitoba

  • Glen Richardson, MD MSc FRCSC · Dalhousie University

  • Douglas Naudie, MD FRCSC · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-04
Primary Completion
2021-11-03
Completion
2024-01-15
FDA Device
Yes

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 NCT03554720 on ClinicalTrials.gov