Clinical Trial

Knee Supports

Study Description

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

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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.

Additional Information

Official Study Title

Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs

Clinical Trial ID

NCT03554720

ParticipAid ID

penn7e