knee osteoarthritis knee wear
Conditions
Sponsors
Zimmer GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is 18 to 75 years of age, inclusive 2. Patient qualifies for a primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy d. Moderate valgus, varus, or flexion deformities e. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee 3. Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form 4. Patient is willing and able to complete scheduled study procedures and follow-up evaluations 5. Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling
Exclusion criteria
Exclusion criteria: 1. Patient is currently participating in any other surgical intervention studies or pain management studies 2. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint 3. Insufficient bone stock on femoral or tibial surfaces 4. Skeletal immaturity 5. Neuropathic arthropathy 6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 7. Stable, painless arthrodesis in a satisfactory functional position 8. Severe instability secondary to the absence of collateral ligament integrity 9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 10. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials 11. Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) 12. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant survivorship based on removal of a study device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety based on incidence and frequency of adverse events. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship. | — |
Countries
Netherlands
Outcome results
None listed