NCT03542045

China ATTUNE® Study

A Prospective Single-arm Multicenter Study to Evaluate Clinical Performance of Cemented ATTUNE® Knee System in Primary Total Knee Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.

Detailed description

The primary objective is to evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs. The subject population is male and female subjects who are candidates for primary, total knee arthroplasty between 18 and 80 years of age, inclusive, willing to consent with indications consistent with the Instructions for Use. A total of 120 subjects will be enrolled in this study.

Conditions

• Osteoarthritis
• Post-traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Cemented ATTUNE® Knee System	This product is for total knee arthroplasty. Four implant configurations are permitted: Cruciate Retaining Fixed Bearing (CR FB), Cruciate Retaining Rotating Platform (CR RP), Posterior Stabilizing Fixed Bearing (PS FB) and Posterior Stabilizing Rotating Platform (PS RP)

Timeline

• Start date: 2018-04-12
• Primary completion: 2021-11-19
• Completion: 2021-11-19
• First posted: 2018-05-31
• Last updated: 2022-04-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study