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

NCT ID: NCT03554720

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2024-01-15

Brief Summary

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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.

Detailed Description

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This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard implants

ATTUNE PS Knee

Group Type ACTIVE_COMPARATOR

ATTUNE PS Knee

Intervention Type DEVICE

The ATTUNE PS Knee is the standard implants.

Enhanced-Fixation

ATTUNE S+ PS Knee

Group Type ACTIVE_COMPARATOR

ATTUNE S+ PS Knee

Intervention Type DEVICE

The ATTUNE S+ PS Knee is the enhanced fixation.

Interventions

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ATTUNE PS Knee

The ATTUNE PS Knee is the standard implants.

Intervention Type DEVICE

ATTUNE S+ PS Knee

The ATTUNE S+ PS Knee is the enhanced fixation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria

* Active or prior infection
* Medical condition precluding major surgery
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orthopaedic Innovation Centre

OTHER

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

Canadian Radiostereometric Analysis Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Turgeon, MD MPH FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Glen Richardson, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Douglas Naudie, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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Concordia Hospital

Winnipeg, Manitoba, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HS21601

Identifier Type: -

Identifier Source: org_study_id

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