Last updated on December 2018

DSJ-2016-07 ATTUNE Cementless CR RP Japan

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03193034

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Hideki Warashina

Nagoya orthopedic Clinic
Kitanagoya, Japan

Recruitment Status: Closed

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