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

Canadian Radiostereometric Analysis Network

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: ATTUNE S+ PS Knee; Device: ATTUNE PS Knee

Study type: Interventional

Funder types: Other

Identifiers

NCT03554720

HS21601

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard implants

Active Comparator group

Description:

ATTUNE PS Knee

Treatment:

Device: ATTUNE PS Knee

Enhanced-Fixation

Active Comparator group

Description:

ATTUNE S+ PS Knee

Treatment:

Device: ATTUNE S+ PS Knee