The ATtune Knee Outcome Study

Rheumatoid Arthritis Clinical Trial

— ATKOS  

Official title:

The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247672
• Other study ID #: 2019.0084
• Status: Recruiting
• Start date: February 3, 2020
• Est. completion date: January 22, 2036

Study information

• Verified date: April 2022
• Source: Spaarne Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Every year, 1.5 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 3.48 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: January 22, 2036
• Est. primary completion date: January 22, 2024
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• End-stage osteoarthritis of the knee warranting joint replacement therapy.

• Indicated for an ATTUNE total knee system as part of regular clinical practice.

• Capability and willingness to sign informed consent and comply with follow-up procedures.

• Capable enough in Dutch or English to be able to understand study procedures

Exclusion Criteria:

• Unable or unwilling to sign informed consent and comply with follow-up

• Indication for primary revision arthroplasty

• Absolute indication for cemented fixation (decreased bone stock/quality of spongiosa)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Rheumatism
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatic Diseases
• Rheumatoid Arthritis

Intervention

Device:
• Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
All patients receive an uncemented ATTUNE rotating platform knee system.

Locations

Country	Name	City	State
Netherlands	Spaarne Gasthuis	Hoofddorp	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.	10 year
Primary	Complication rate	All substantial complications associated with total knee arthroplasty will be registered and reported	10 year
Primary	Forgotten Joint Score 12 (FJS-12)		10 year
Primary	Kujala Anterior Knee Pain Scale (AKPS)		10 year
Primary	Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form	KOOS-PS	10 year
Primary	Numeric Rating Scale (NRS)	NRS on pain and satisfaction	10 year
Primary	EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)		10 year
Secondary	30 second chair stand test (30sCST)	The amount of times one can stand up and sit down from a chair in 30 seconds	1 year
Secondary	40m Fast paced walk test (40m-FPWT)	The amount of seconds one does to walk 40 meters.	1 year
Secondary	Stair climb test (SCT)	The time one takes to walk a set of stairs up and down.	1 year
Secondary	Tegner activity rating scale	1-item questionnaire	1 year
Secondary	University of California, Los Angeles (UCLA) activity rating scale	1-item questionnaire	1 year
Secondary	Return to work	Assessed by a short self-composed questionnaire, which evaluates what kind of work the patients do, when they started after surgery and whether this is the same as their preoperative job	1 year
Secondary	Alignment	A long-leg radiograph is performed 1 year after surgery to assess mechanical alignment of the prosthesis with consideration of femur and tibia	1 year
Secondary	Patient Health Questionnaire (PHQ-2)	2-item questionnaire to screen for major depressive episodes	10 year
Secondary	Pain Self Efficacy Questionnaire (PSEQ)	Questionnaire to asses pain self efficacy	10 year
Secondary	Pain Catastrophizing Scale (PCS)	Explores pain catastrophizing and its relation to pain behaviour	10 year