Status:
ACTIVE_NOT_RECRUITING
Persona Total Knee Arthroplasty Outcomes Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Knee Pain Chronic
Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The ass...
Detailed Description
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain IRB approval prior to study enrollme...
Eligibility Criteria
Inclusion
- Patient 18-75 years of age, inclusive
- Patient qualifies for 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; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
- Patient has participated in a study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
- Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling
Exclusion
- Patient is currently participating in any other surgical intervention studies or pain management studies
- 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
- Skeletal immaturity
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- Stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
737 Patients enrolled
Trial Details
Trial ID
NCT02255383
Start Date
July 1 2014
End Date
December 1 2027
Last Update
August 27 2025
Active Locations (14)
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1
Colorado Joint Replacement
Denver, Colorado, United States, 80210
2
Orthopaedic & Spine Center of the Rockies
Fort Collins, Colorado, United States, 80525
3
Denver-Vail Orthopedics
Parker, Colorado, United States, 80134
4
Rockford Orthopedic Associates
Rockford, Illinois, United States, 61114