Persona Netherlands Study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Patient is 18 to 75 years of age
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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Implant survivorship based on removal of a study device. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety based on incidence and frequency of adverse events. Clinical performance<br /><br>measured by overall pain and function, quality of life data, radiographic<br /><br>parameters and survivorship.</p><br>