Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

Non-inflammatory Degenerative Joint Disease Clinical Trial

Official title: Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty

Status Completed

Clinical Trial Summary

This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).

Clinical Trial Description

This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees).

This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care.

Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP). ;

Related Conditions & MeSH terms

• Joint Diseases
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis

• NCT number: NCT02339610
• Study type: Observational
• Source: DePuy Orthopaedics
• Status: Completed
• Start date: January 1, 2015
• Completion date: June 28, 2019