Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02839850
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2016-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Sponsor:
DePuy Orthopaedics
Organization:
Study Overview
Official Title:
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 of this study is to examine 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). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Detailed Description:
The secondary objectives of this study are:
* 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 and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
* Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
* Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
* 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 and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
* Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
* Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: