NCT03193034

DSJ-2016-07 ATTUNE® Cementless CR RP Japan

Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to investigate 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) in the Japanese patient population.

Detailed description

* 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 configurations using Kaplan-Meier survival analysis at 1 and 2yrs. * Evaluate primary, cementless ATTUNE® TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 1yr, and 2yrs after surgery. * Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs. * Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.

Conditions

• Osteoarthritis

Interventions

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

Timeline

• Start date: 2017-06-30
• Primary completion: 2020-12-22
• Completion: 2021-06-30
• First posted: 2017-06-20
• Last updated: 2021-09-29

Locations

4 sites across 1 country: Japan