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Persona Partial Knee Clinical Outcomes Study

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ClinicalTrials.gov Identifier: NCT03034811
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Avascular Necrosis Traumatic Arthritis Conditional Tibial Condyle or Plateau Fractures Conditional Revision of the Articular Surface Device: Persona Partial Knee system Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persona Partial Knee Clinical Outcomes Study
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
PPK subjects
Subjects that receive the Persona Partial Knee system
 Device: Persona Partial Knee system
Fixed bearing partial knee


Outcome Measures
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Primary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 10 years ]
    A Patient reported functional outcome score for knee arthroplasty


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 10 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034811


Contacts
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Contact: Tory Sears 574-373-2125 Tory.Sears@zimmerbiomet.com
Contact: Kacy Arnold, RN, MBA 574-371-9824 kacy.arnold@zimmerbiomet.com

  Show 26 Study Locations
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03034811     History of Changes
Other Study ID Numbers: K.CR.I.G.16.16
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zimmer Biomet:
Noninflammatory degenerative joint disease
Osteoarthritis
Avascular necrosis
 Traumatic arthritis
Partial knee arthroplasty
Unicompartmental knee arthroplasty

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteonecrosis
Necrosis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Bone Diseases