Persona Partial Knee Clinical Outcomes Study

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Zimmer Biomet

Status

Active, not recruiting

Conditions

Traumatic Arthritis
Osteoarthritis
Conditional Tibial Condyle or Plateau Fractures
Avascular Necrosis
Conditional Revision of the Articular Surface

Treatments

Device: Persona Partial Knee system

Study type

Interventional

Funder types

Industry

Identifiers

NCT03034811
K.CR.I.G.16.16

Details and patient eligibility

About

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

Full 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.

Enrollment

643 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

643 participants in 1 patient group

PPK subjects
Other group
Description:
Subjects that receive the Persona Partial Knee system
Treatment:
Device: Persona Partial Knee system

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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