RecruitingNot Applicable

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

United States760 participantsStarted 2023-06-28

Plain-language summary

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary 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 Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document
✓. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
✓. Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling

Exclusion criteria

✕. 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 neurological condition who is unwilling or incapable of following postoperative care instructions
✕. Patient has a condition which would, in the judgment 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
✕. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
✕. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
✕. Insufficient bone stock on femoral or tibial surfaces

What they're measuring

Oxford Knee Score (OKS)

Timeframe: 5 years

Trial details

NCT IDNCT05787821

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Erik Kowalski, PhD

6473316652 erik.kowalski@zimmerbiomet.com

View on ClinicalTrials.gov More Knee Pain Chronic trials