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Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Active, not recruitingNCT05787821
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation
Conditions
Interventions
  • Device: Total Knee Arthroplasty
Sponsor
Zimmer Biomet
Start date
2023-06-28
Primary completion
2026-06-30
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
16

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patient is of legal age and skeletally mature 2. 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 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. 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: 1. Patient is currently participating in any other surgical intervention or pain management study 2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent) 3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions 4. 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 5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty 7. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint 8. Insufficient bone stock on femoral or tibial surfaces 9. Neuropathic arthropathy 10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 11. A stable, painless arthrodesis in a satisfactory functional position 12. Severe instability secondary to the absence of collateral ligament integrity 13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 14. Patient has a \> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05787821