Rheumatoid Arthritis Clinical Trial
Official title:
Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System
Verified date | August 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 assessment will include implant survivorship and clinical performance.
Status | Active, not recruiting |
Enrollment | 737 |
Est. completion date | December 2027 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UNC Department of Orthopaedics | Chapel Hill | North Carolina |
United States | OrthoCarolina | Charlotte | North Carolina |
United States | Lindner Research Center | Cincinnati | Ohio |
United States | SportsMedicine Grant & Orthopaedic Associates | Columbus | Ohio |
United States | Colorado Joint Replacement | Denver | Colorado |
United States | Orthopaedic & Spine Center of the Rockies | Fort Collins | Colorado |
United States | Tennessee Orthopaedic Foundation for Education and Research | Knoxville | Tennessee |
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
United States | Henry County Orthopedics and Sports Medicine | New Castle | Indiana |
United States | Denver-Vail Orthopedics | Parker | Colorado |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Raleigh Orthopaedic Clinic | Raleigh | North Carolina |
United States | Rockford Orthopedic Associates | Rockford | Illinois |
United States | Jordan Young Institute | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Society Score | Knee Society Score | 10 years | |
Secondary | EQ-5D | EQ-5D | 10 years |
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