NCT04079751

Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Neutral Mechanical Alignment	Hip-knee-ankle angle of 180° ± 3°.
PROCEDURE	Anatomical Alignment	Restoring a patient's pre-diseased limb alignment

Timeline

• Start date: 2019-05-05
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2019-09-06
• Last updated: 2025-12-04

Locations

2 sites across 1 country: Canada