NCT03153475

ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

Detailed description

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship. The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed. Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.

Conditions

• Revision Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	ATTUNE Revision Knee System in Revision Total Knee Arthroplasty	Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.

Timeline

• Start date: 2017-05-30
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2017-05-15
• Last updated: 2026-04-13

Locations

38 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, New Zealand, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study