Zimmer POLAR Persona - TKA (EMEA Study)

  • STATUS
    Recruiting
  • End date
    Nov 5, 2027
  • participants needed
    600
  • sponsor
    Zimmer, GmbH
Updated on 5 February 2021
Investigator
Wing To
Primary Contact
CHU de Clermont-Ferrand (0.0 mi away) Contact
+13 other location
osteoarthritis
total knee replacement
rheumatism
knee pain
rheumatoid arthritis
avascular necrosis
polyarthritis
traumatic arthritis
patellectomy
traumatic loss
erosion
joint reconstruction
collagen disorders

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:

  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.

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.

Details
Condition Rheumatoid Arthritis, Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Rheumatoid Arthritis (Pediatric), Traumatic Arthritis, Severe Knee Pain, Severe Knee Disability, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis, polyarthritis, polyarticular arthritis
Treatment Zimmer Persona Total Knee System
Clinical Study IdentifierNCT02337244
SponsorZimmer, GmbH
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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