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Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

NCT05787821

Active Not RecruitingN/A

Sponsor: Zimmer Biomet

Conditions: Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis

Interventions: Total Knee Arthroplasty

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (16)
  • Parker, Colorado, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Louisville, Kentucky, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • Jackson, Mississippi, United States
  • Albuquerque, New Mexico, United States
  • DeWitt, New York, United States
  • New York, New York, United States
  • Roslyn, New York, United States
  • Charlotte, North Carolina, United States
  • Morrisville, North Carolina, United States
  • Cleveland, Ohio, United States
  • Houston, Texas, United States
  • Charlottesville, Virginia, United States