- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247672
The ATtune Knee Outcome Study (ATKOS)
The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Noord-Holland
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Hoofddorp, Noord-Holland, Netherlands, 2134 TM
- Recruiting
- Spaarne Gasthuis
-
Contact:
- Marjolein Schager, Registered Nurse
- Phone Number: 023 22 41673
- Email: mschager@spaarnegasthuis.nl
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Principal Investigator:
- Peter A Nolte, Orthopedic Surgeon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Time Frame: 10 year
|
Calculated by determining revision rate.
Septic, aseptic and all-cause revision rates will be calculated seperately.
|
10 year
|
Complication rate
Time Frame: 10 year
|
All substantial complications associated with total knee arthroplasty will be registered and reported
|
10 year
|
Forgotten Joint Score 12 (FJS-12)
Time Frame: 10 year
|
10 year
|
|
Kujala Anterior Knee Pain Scale (AKPS)
Time Frame: 10 year
|
10 year
|
|
Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form
Time Frame: 10 year
|
KOOS-PS
|
10 year
|
Numeric Rating Scale (NRS)
Time Frame: 10 year
|
NRS on pain and satisfaction
|
10 year
|
EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)
Time Frame: 10 year
|
10 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 second chair stand test (30sCST)
Time Frame: 1 year
|
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)
Time Frame: 1 year
|
The amount of seconds one does to walk 40 meters.
|
1 year
|
Stair climb test (SCT)
Time Frame: 1 year
|
The time one takes to walk a set of stairs up and down.
|
1 year
|
Tegner activity rating scale
Time Frame: 1 year
|
1-item questionnaire
|
1 year
|
University of California, Los Angeles (UCLA) activity rating scale
Time Frame: 1 year
|
1-item questionnaire
|
1 year
|
Return to work
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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)
Time Frame: 10 year
|
2-item questionnaire to screen for major depressive episodes
|
10 year
|
Pain Self Efficacy Questionnaire (PSEQ)
Time Frame: 10 year
|
Questionnaire to asses pain self efficacy
|
10 year
|
Pain Catastrophizing Scale (PCS)
Time Frame: 10 year
|
Explores pain catastrophizing and its relation to pain behaviour
|
10 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.0084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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