Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04247672
Status:
RECRUITING
Last Update Posted:
2022-04-27
First Post:
2020-01-20
Brief Title:
The ATtune Knee Outcome Study
Sponsor:
Spaarne Gasthuis
Organization:
Spaarne Gasthuis
Study Overview
Official Title:
The ATtune Knee Outcome Study Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2022-04
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:
ATKOS
Brief Summary:
To accomodate dissatisfied patients with a total knee arthroplasty TKA and improve outcomes several knee systems have been developed The cemented ATTUNE TKA shows superiority over other established knee systems at short-term abating with longer follow-up There have been no studies reporting on the results of the uncemented version of the ATTUNE Therefore the main objective of the current study was to report patient reported outcome measures PROMs survivorship and complications associated with the uncemented ATTUNE TKA
Detailed Description:
Every year 15 million total knee arthroplasties TKA are performed worldwide in patients whose joints have been severely affected by osteoarthritis rheumatoid arthritis or trauma causing intense pain and loss of function Due to the ageing society these numbers are expected to have increased six-fold to 348 million cases annually by 2030 Even though joint replacement provides satisfactory and durable results for most patients 20 is thought to still not be satisfied with their artificial joint To accommodate this dissatisfied population and improve durability of implants even more several knee systems have been developed over the years One of the newest models is the ATTUNE knee system DePuy Warsaw Indiana USA One of the landmark features is a gradually reducing radius in the geometry of the femoral component more closely mimicking the anatomical patellofemoral joint and facilitating more natural femoral rollback during flexion Comparisons of the cemented ATTUNE with previous knee systems show promising results in terms of patellofemoral outcomes but fail to demonstrate definitive superiority in terms of all patient reported outcomes Clinical superiority of the ATTUNE tends to abate with longer follow-up implicating a possible superiority in the short-term recovery and return to activities There is no follow-up study reporting the results of the uncemented ATTUNE Moreover all previously cited studies report better patellofemoral outcomes with patellar resurfacing making it still unclear whether the implicated superior design changes of the femoral component hold ground without patellar resurfacing
The primary objective is to report survivorship complications and patient reported outcome measures associated with the uncemented ATTUNE rotating platform knee system Secondary objectives are 1 evaluate patient reported patellofemoral outcomes 2 assess return to work and sport after TKA 3 translate and validate the Dutch version of the University of California Los Angeles UCLA activity scale and 4 analyse psychologic factors such as pain catastrophising and coping and the impact on dissatisfaction following TKA
The primary objective is to report survivorship complications and patient reported outcome measures associated with the uncemented ATTUNE rotating platform knee system Secondary objectives are 1 evaluate patient reported patellofemoral outcomes 2 assess return to work and sport after TKA 3 translate and validate the Dutch version of the University of California Los Angeles UCLA activity scale and 4 analyse psychologic factors such as pain catastrophising and coping and the impact on dissatisfaction following TKA
Study Oversight
Has Oversight DMC:
None
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?:
None