Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

Knee Osteoarthritis Clinical Trial

Official title: Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Anatomic (Femur First) to Neutral Mechanical Alignment Techniques

Status Completed

Clinical Trial Summary

The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.

Clinical Trial Description

This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:

1. Neutral mechanical alignment;

2. Anatomical alignment.

The principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system 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, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery. ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT04079751
• Study type: Interventional
• Source: Canadian Radiostereometric Analysis Network
• Status: Completed
• Phase: N/A
• Start date: May 5, 2019
• Completion date: February 1, 2022