Triathlon PSR Outcomes Study

  • STATUS
    Recruiting
  • End date
    Feb 25, 2033
  • participants needed
    250
  • sponsor
    Stryker Orthopaedics
Updated on 25 March 2022

Summary

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.

Details
Condition Arthroplasty, Knee
Treatment Triathlon PSR Tibial Insert
Clinical Study IdentifierNCT04618770
SponsorStryker Orthopaedics
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form
Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
Patient is a candidate for primary cemented total knee replacement
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

Exclusion Criteria

Patient has a Body Mass Index (BMI) > 45\
Patient is already participating in the study for a contralateral total knee replacement
Patient has a diagnosis of avascular necrosis or inflammatory arthritis
Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation
Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care
Patient has a compromised bone stock which cannot provide adequate support to the prosthesis
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
Patient is diagnosed with lumbar radicular pain
Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function
Patient has a known sensitivity to device materials
Patient is a prisoner
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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