Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs

*Ethics Approved – have not started recruitment at NSHA site

Eligibility

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:

  • Active or prior infection
  • Medical condition precluding major surgery

Contact

PI
Dr. Glen Richardson

Description

DePuy-Synthes (Warsaw, IN) has recently released a new version of their existing Attune total knee replacement system which incorporates several features aimed at improving implant-cement fixation of the tibial component and in an effort to improve the initial and long-term fixation of the implant. It is important to assess the efficacy of technological improvements in arthroplasty devices using high-precision metrics such as radiostereometric analysis. We propose a multi-centre randomized controlled trial examining differences in early stability of the traditional (Attune) versus enhanced-fixation (Attune S+) tibial component designs of the Attune posterior-stabilized knee systems. This study will involve ­­50 patients undergoing total knee arthroplasty with a follow-up period of 2 years. The primary metric of this study will be difference in tibial baseplate and femoral component migration between Attune system designs, as measured by model-based radiostereometric analysis. Secondary metrics shall include improvement in patient reported health and function from pre- to post-operative as well as occurrence of clinical complications and adverse events.

Study Objective:

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.

Sample size= 50 (25 per site)