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Zimmer POLAR - Total Knee Arthroplasty (TKA)

Sponsor
Zimmer Biomet (Industry)
Overall Status
Completed
CT.gov ID
NCT01859130
Collaborator
(none)
300
Enrollment
4
Locations
1
Arm
98.3
Actual Duration (Months)
75
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Zimmer Persona Total Knee System
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
Actual Study Start Date :
Oct 21, 2013
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Knee Society Scores [5 years post op]

      Knee Society Scores

    Secondary Outcome Measures

    1. EQ-5D [5 years post op]

      EQ-5D

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Midwest Orthopaedics at Rush Naperville Illinois United States 60563
    2 The Rothman Institute Egg Harbor Township New Jersey United States 08234
    3 Duke University Durham North Carolina United States 27701
    4 The Rothman Institute Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Zimmer Biomet

    Investigators

    • Study Director: Kacy Arnold, RN MBA, Zimmer Biomet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT01859130
    Other Study ID Numbers:
    • CSU2012-10K
    First Posted:
    May 21, 2013
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Arthritis

    Study Results

    No Results Posted as of Jan 21, 2022