Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-10 @ 5:42 PM
Study NCT ID:
NCT03193034
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2017-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DSJ-2016-07 ATTUNE® Cementless CR RP Japan
Sponsor:
DePuy Orthopaedics
Organization:
Study Overview
Official Title:
Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: