Zimmer POLAR Persona - TKA (EMEA Study)

Zimmer Biomet

Status: Active, not recruiting

Conditions: Traumatic Arthritis; Osteoarthritis; Severe Knee Disability; Polyarthritis; Severe Knee Pain; Rheumatoid Arthritis

Treatments: Device: Zimmer Persona Total Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT02337244

CSE2013-07K

Details and patient eligibility

About

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:

1. Implant survivorship based on removal of a study device.
2. Safety based on incidence and frequency of adverse events.
3. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Full 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.

Enrollment: 777 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.
• 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.