The ATtune Knee Outcome Study (ATKOS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Knee Osteoarthritis; Osteoarthritis, Knee; Knee Rheumatism
• Intervention / Treatment: Device: Total Knee Arthroplasty (uncemented rotating platform ATTUNE)

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Hoofddorp, Noord-Holland, Netherlands, 2134 TM
      • Recruiting
      • Spaarne Gasthuis
      • Contact: Marjolein Schager, Registered Nurse; Phone Number: 023 22 41673; Email: mschager@spaarnegasthuis.nl
      • Principal Investigator: Peter A Nolte, Orthopedic Surgeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with end-stage knee disease (e.g. knee osteoarthritis) warranting and able to undergo knee replacement therapy.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.	10 year
Complication rate	All substantial complications associated with total knee arthroplasty will be registered and reported	10 year
Forgotten Joint Score 12 (FJS-12)		10 year
Kujala Anterior Knee Pain Scale (AKPS)		10 year
Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form	KOOS-PS	10 year
Numeric Rating Scale (NRS)	NRS on pain and satisfaction	10 year
EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)		10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
40m Fast paced walk test (40m-FPWT)	The amount of seconds one does to walk 40 meters.	1 year
Stair climb test (SCT)	The time one takes to walk a set of stairs up and down.	1 year
Tegner activity rating scale	1-item questionnaire	1 year
University of California, Los Angeles (UCLA) activity rating scale	1-item questionnaire	1 year
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
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
Patient Health Questionnaire (PHQ-2)	2-item questionnaire to screen for major depressive episodes	10 year
Pain Self Efficacy Questionnaire (PSEQ)	Questionnaire to asses pain self efficacy	10 year
Pain Catastrophizing Scale (PCS)	Explores pain catastrophizing and its relation to pain behaviour	10 year

Collaborators and Investigators

• Sponsor: Spaarne Gasthuis

Publications and helpful links

General Publications

• Rassir R, Sierevelt IN, Schager M, Nolte PA; ATKOS group. Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system. BMC Musculoskelet Disord. 2021 Jul 15;22(1):622. doi: 10.1186/s12891-021-04493-1.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Anticipated): January 22, 2024
• Study Completion (Anticipated): January 22, 2036

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Rheumatic Diseases
• Other Study ID Numbers: 2019.0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No