Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Knee Pain
- Sponsor
- Zimmer, GmbH
- Enrollment
- 777
- Locations
- 12
- Primary Endpoint
- Kaplan-Meier Implant Survivorship
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:
- Implant survivorship based on removal of a study device.
- 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.
Detailed Description
This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.
Investigators
Eligibility Criteria
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:
- •rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
- •collagen disorders and/or avascular necrosis of the femoral condyle;
- •post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- •moderate valgus, varus, or flexion deformities;
- •the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
- •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 Zimmer Persona knee implants 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.
Outcomes
Primary Outcomes
Kaplan-Meier Implant Survivorship
Time Frame: 5 years
Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.
Secondary Outcomes
- 'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.(5 years)
- Oxford Knee Score (OKS)(5 years)
- EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)(5 years)
- 'Forgotten Joint Score' (FJS-12)(5 years)