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Persona Partial Knee Clinical Outcomes Study

Primary Purpose

Osteoarthritis, Avascular Necrosis, Traumatic Arthritis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Persona Partial Knee system
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Noninflammatory degenerative joint disease, Osteoarthritis, Avascular necrosis, Traumatic arthritis, Partial knee arthroplasty, Unicompartmental knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is at least 18 years of age
  • Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.
  • Patient has participated in a study-related Informed Consent process
  • Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent form
  • Patient is willing and able to complete scheduled study procedures and follow-up evaluations
  • Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee, implanted in accordance with product labeling

Exclusion Criteria:

  • Patient is currently participating in any other surgical intervention studies or pain management studies
  • Infection, sepsis, and osteomyelitis
  • Rheumatoid arthritis or other forms of inflammatory joint disease
  • Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
  • Full thickness damage to the weight bearing area of the contralateral compartment
  • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  • Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, neuromuscular disease
  • Incomplete or deficient soft tissue surrounding the knee
  • Charcot's disease
  • Fixed varus deformity (not passively correctable) of greater than 15 degrees
  • Fixed flexion deformity (not passively correctable) of greater than 15 degrees
  • Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Sites / Locations

  • Sah Orthopaedic Associates
  • Panorama Orthopedics & Spine Center
  • Midwest Orthopaedics at Rush
  • Henry County Orthopedics and Sports Medicine
  • Sports Medicine North
  • Troy Orthopaedic Associates
  • New Mexico Orthopaedics
  • Midlands Orthopaedics & Neurosurgery
  • Skagit Regional Clinics-Riverbend
  • Orthopädisches Spital Speising
  • Cliniques Universitaires Saint-Luc
  • Marseille University-Hospital Centres
  • Public Hospital of Versailles
  • Hessing Stiftung
  • Sana Kliniken Sommerfeld
  • Waldkrankenhaus Eisenberg
  • Orthopedic Institute IRCCS
  • Fondazione IRCCS Policlinico San Matteo
  • Hospital Alcorcón
  • Umea University Hospital
  • Hopital d'Yverdon les Bains
  • Avon Orthopaedic Centre, Southmead Hospital
  • Royal Derby Hospital
  • Harrogate and District NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PPK subjects

Arm Description

Subjects that receive the Persona Partial Knee system

Outcomes

Primary Outcome Measures

Oxford Knee Score
A Patient reported functional outcome score for knee arthroplasty

Secondary Outcome Measures

EQ-5D
a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.

Full Information

First Posted
January 25, 2017
Last Updated
August 27, 2023
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT03034811
Brief Title
Persona Partial Knee Clinical Outcomes Study
Official Title
Persona Partial Knee Clinical Outcomes Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
July 2029 (Anticipated)

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 the commercially available Persona Partial Knee System.
Detailed Description
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. The study will require each site to obtain 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 partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively. The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters, and survivorship.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Conditional Tibial Condyle or Plateau Fractures, Conditional Revision of the Articular Surface
Keywords
Noninflammatory degenerative joint disease, Osteoarthritis, Avascular necrosis, Traumatic arthritis, Partial knee arthroplasty, Unicompartmental knee arthroplasty

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PPK subjects
Arm Type
Other
Arm Description
Subjects that receive the Persona Partial Knee system
Intervention Type
Device
Intervention Name(s)
Persona Partial Knee system
Intervention Description
Fixed bearing partial knee
Primary Outcome Measure Information:
Title
Oxford Knee Score
Description
A Patient reported functional outcome score for knee arthroplasty
Time Frame
10 years
Secondary Outcome Measure Information:
Title
EQ-5D
Description
a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is at least 18 years of age Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system. Patient has participated in a study-related Informed Consent process Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent form Patient is willing and able to complete scheduled study procedures and follow-up evaluations Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee, implanted in accordance with product labeling Exclusion Criteria: Patient is currently participating in any other surgical intervention studies or pain management studies Infection, sepsis, and osteomyelitis Rheumatoid arthritis or other forms of inflammatory joint disease Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device Full thickness damage to the weight bearing area of the contralateral compartment Uncooperative patient or patient with neurologic disorders who is incapable of following directions Insufficient bone stock to provide adequate support and/or fixation to the prosthesis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, neuromuscular disease Incomplete or deficient soft tissue surrounding the knee Charcot's disease Fixed varus deformity (not passively correctable) of greater than 15 degrees Fixed flexion deformity (not passively correctable) of greater than 15 degrees Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Overholser
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Sah Orthopaedic Associates
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Panorama Orthopedics & Spine Center
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Midwest Orthopaedics at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Henry County Orthopedics and Sports Medicine
City
New Castle
State/Province
Indiana
ZIP/Postal Code
47362
Country
United States
Facility Name
Sports Medicine North
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Troy Orthopaedic Associates
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
New Mexico Orthopaedics
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Midlands Orthopaedics & Neurosurgery
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Skagit Regional Clinics-Riverbend
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Orthopädisches Spital Speising
City
Vienna
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Woluwe-Saint-Lambert
Country
Belgium
Facility Name
Marseille University-Hospital Centres
City
Marseille
Country
France
Facility Name
Public Hospital of Versailles
City
Versailles
Country
France
Facility Name
Hessing Stiftung
City
Augsburg
Country
Germany
Facility Name
Sana Kliniken Sommerfeld
City
Berlin
Country
Germany
Facility Name
Waldkrankenhaus Eisenberg
City
Eisenberg
Country
Germany
Facility Name
Orthopedic Institute IRCCS
City
Milan
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Hospital Alcorcón
City
Madrid
Country
Spain
Facility Name
Umea University Hospital
City
Umea
Country
Sweden
Facility Name
Hopital d'Yverdon les Bains
City
Yverdon les Bains
Country
Switzerland
Facility Name
Avon Orthopaedic Centre, Southmead Hospital
City
Bristol
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom
Facility Name
Harrogate and District NHS Foundation Trust
City
Harrogate
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Persona Partial Knee Clinical Outcomes Study

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