DSJ-2016-07 ATTUNE® Cementless CR RP Japan

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Osteoarthritis

Clinical Trial Details

NCT number	NCT03193034
Study type	Interventional
Source	DePuy Orthopaedics
Contact
Status	Completed
Phase	N/A
Start date	June 30, 2017
Completion date	June 30, 2021

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