Zimmer POLAR - Total Knee Arthroplasty (TKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Zimmer, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01859130
First received: May 16, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 measured by pain and function, quality of life data, radiographic parameters and survivorship.


Condition Intervention
Osteoarthritis,
Rheumatoid Arthritis,
Traumatic Arthritis,
Polyarthritis
Device: Zimmer Persona Total Knee System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Knee Society Scores [ Time Frame: 5 years post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EQ-5D [ Time Frame: 5 years post op ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Persona TKA
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Device: Zimmer Persona Total Knee System
Other Names:
  • Primary Knee Replacement,
  • Total Knee Arthroplasty,
  • Total Knee Replacement

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 Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic patients that are in need of a total knee arthroplasty

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 has participated in a study-related Informed Consent process;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859130

Contacts
Contact: David W Fawley, MS 574-371-1924 david.fawley@zimmer.com
Contact: Kacy Arnold, RN, MBA 574-371-8336 kacy.arnold@zimmer.com

Locations
United States, Illinois
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Contact: Stefanie Miller    630-933-6254      
Principal Investigator: Scott Sporer, MD         
United States, New Jersey
The Rothman Institute Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Victoria Younger    609-677-7015    victoria.younger@rothmaninstitute.com   
Principal Investigator: Fabio Orozco, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27701
Contact: Jennifer Friend    919-668-4373    jennifer.friend@duke.edu   
Principal Investigator: Samuel Wellman, MD         
Sub-Investigator: Michael Bolognesi, MD         
United States, Pennsylvania
The Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Brian Urbani       Brian.urbani@rothmaninstitute.com   
Principal Investigator: Matthew Austin, MD         
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01859130     History of Changes
Other Study ID Numbers: CSU2012-10K
Study First Received: May 16, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:
osteoarthritis,
rheumatoid arthritis,
traumatic arthritis,
polyarthritis,
total knee arthroplasty

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014