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Zimmer POLAR - Total Knee Arthroplasty (TKA)

Primary Purpose

Osteoarthritis, RheumatoId Arthritis, Traumatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zimmer Persona Total Knee System
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Midwest Orthopaedics at Rush
  • The Rothman Institute
  • Duke University
  • The Rothman Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Persona TKA

Arm Description

Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

Outcomes

Primary Outcome Measures

Knee Society Scores
This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.

Secondary Outcome Measures

EQ-5D
The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death.
Forgotten Joint Score (FJS)
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement).

Full Information

First Posted
May 16, 2013
Last Updated
October 12, 2023
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01859130
Brief Title
Zimmer POLAR - Total Knee Arthroplasty (TKA)
Official Title
Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2013 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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. All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, RheumatoId Arthritis, Traumatic Arthritis, Polyarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Persona TKA
Arm Type
Other
Arm Description
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Intervention Type
Device
Intervention Name(s)
Zimmer Persona Total Knee System
Other Intervention Name(s)
Primary Knee Replacement,, Total Knee Arthroplasty,, Total Knee Replacement
Primary Outcome Measure Information:
Title
Knee Society Scores
Description
This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.
Time Frame
5 years post op
Secondary Outcome Measure Information:
Title
EQ-5D
Description
The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death.
Time Frame
5 years post op
Title
Forgotten Joint Score (FJS)
Description
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement).
Time Frame
5 years post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kacy Arnold, RN MBA
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Midwest Orthopaedics at Rush
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
The Rothman Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
The Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zimmer POLAR - Total Knee Arthroplasty (TKA)

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