NCT04247672

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Feb 2020Jan 2036

First Submitted

Initial submission to the registry

January 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
12 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2036

Expected
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

January 20, 2020

Last Update Submit

April 26, 2022

Conditions

Osteoarthritis, KneeKnee OsteoarthritisKnee RheumatismRheumatoid Arthritis

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (10)

  • 30 second chair stand test (30sCST)

    1 year

  • 40m Fast paced walk test (40m-FPWT)

    1 year

  • Stair climb test (SCT)

    1 year

  • Tegner activity rating scale

    1 year

  • University of California, Los Angeles (UCLA) activity rating scale

    1 year

  • +5 more secondary outcomes

Interventions

Total Knee Arthroplasty (uncemented rotating platform ATTUNE)DEVICE

All patients receive an uncemented ATTUNE rotating platform knee system.

Also known as: Total knee arthroplasty

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaarne Gasthuis

Hoofddorp, North Holland, 2134 TM, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34266444DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeArthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 30, 2020

Study Start

February 3, 2020

Primary Completion

January 22, 2024

Study Completion (Estimated)

January 22, 2036

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)