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CompletedNCT02103504Updated Feb 1, 2019

DePuy Attune Total Knee Arthroplasty RSA Study

An interventional study of DePuy Attune posterior stabilized fixed bearing total knee replacement in Osteoarthritis, sponsored by Michael Dunbar. Completed at 3 sites in Canada. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Michael Dunbar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
21 Years to 80 Years
Sex
All
01

Study summary

The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.

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Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Michael Dunbar is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion criteria

Exclusion Criteria:

  • Active or prior infection
  • Medical condition precluding major surgery
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    DePuy Attune TKA

    DePuy Attune posterior stabilized fixed bearing total knee replacement

    Device: DePuy Attune posterior stabilized fixed bearing total knee replacement

Interventions

  • DeviceDePuy Attune posterior stabilized fixed bearing total knee replacement
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What researchers measure

Primary outcomes

  1. Implant migration

    Time frame: 2 years

Secondary outcomes

  1. Functional range of motion

    Time frame: 2 years

  2. Self-reported health status

    EQ-5D score

    Time frame: 2 years

  3. Self-reported joint status

    Time frame: 2 years

07

Study locations

3 sites
  • Concordia Hospital
    Winnipeg, Manitoba, Canada
  • Capital District Health Authority
    Halifax, Nova Scotia B3H 3A7, Canada
  • Hopital Maisonneuve-Rosemont
    Montreal, Quebec, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02103504
Lead sponsor
Michael Dunbar
Collaborators
Concord Hospital, Maisonneuve-Rosemont Hospital
Responsible party
Michael Dunbar (Orthopedic Surgeon, Nova Scotia Health Authority) — Sponsor-investigator
First posted
Apr 4, 2014
Start date
Jul 2014
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Feb 1, 2019

Study contacts

Michael Dunbar
principal investigator · Capital Health, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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