NCT06189872

Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement

Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

Detailed description

All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Attune Cementless	* Attune AFFIXIUM Cementless Tibial Baseplate, Fixed Bearing * Attune POROCOAT Cementless Femoral Component, Cruciate Retaining * Attune AOX Antioxidant Polyethylene Tibial Insert, Cruciate Retaining * Attune AOX Patellar Button, Domed or Medialized Dome, Cemented or Cementless (surgeon preference for resurfacing)

Timeline

• Start date: 2024-10-21
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-01-05
• Last updated: 2025-12-04

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated device study