NCT02839850

14022 ATTUNE Cementless RP Clinical Performance Evaluation

Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

Detailed description

The secondary objectives of this study are: * Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L. * Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr. * Evaluate type and frequency of Adverse Events * Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs. * Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery. * Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Cementless Total Knee Arthroplasty	Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)

Timeline

• Start date: 2016-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2016-07-21
• Last updated: 2026-04-13

Locations

20 sites across 9 countries: United States, Austria, Canada, France, Germany, Ireland, Netherlands, New Zealand, United Kingdom

Regulatory

• FDA-regulated device study