Active — Not RecruitingNot Applicable

Persona Ti-Nidium Post-Market Clinical Follow-up

United States240 participantsStarted 2021-06-01

Plain-language summary

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is of legal age and skeletally mature
✓. Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
✓. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
✓. Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface
✓. Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling
✓. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
✓. Collagen disorders, and/or avascular necrosis of the femoral condyle.
✓. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

Exclusion criteria

✕. Patient is unwilling to sign the Informed Consent
✕. Patient is currently participating in any other surgical intervention or pain management study
✕. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
✕. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
✕. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
✕. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
✕. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
✕. Insufficient bone stock on femoral or tibial surfaces

What they're measuring

Oxford Knee Score (OKS)

Timeframe: 10 years

Trial details

NCT IDNCT04817969

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2034-05

View on ClinicalTrials.gov More Knee Pain Chronic trials