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CompletedNo phase

RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

Key facts

Who runs it
Canadian Radiostereometric Analysis Network
Where
Canada2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
50 people enrolled
Started
4 Jul 2018
Ended
15 Jan 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ATTUNE PS Knee
  • ATTUNE S+ PS Knee
Record updated
17 January 2024

Who can take part

Age
21 years to 80 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active or prior infection
  • Medical condition precluding major surgery

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.

The 2 groups in the trial

  • Standard implantsExisting treatment, for comparison

    ATTUNE PS Knee

    Treatment: ATTUNE PS Knee

  • Enhanced-FixationExisting treatment, for comparison

    ATTUNE S+ PS Knee

    Treatment: ATTUNE S+ PS Knee

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs
Record updated
17 January 2024