Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
80

Summary

Conditions
Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: An independent radiographic reviewer will be assessing all radiographs from the study.Primary Purpose: Treatment

Participation Requirements

Age
Between 22 years and 80 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03193034
Collaborators
Johnson & Johnson K.K. Medical Company
Investigators
Study Director: Sue Kemp, B.Sc., Ph.D. Sponsor GmbH
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