Persona Partial Knee Clinical Outcomes Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Zimmer Biomet
- Enrollment
- 757
- Locations
- 35
- Primary Endpoint
- Oxford Knee Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.)
Arms & Interventions
PPK subjects
Subjects that receive the Persona Partial Knee system
Intervention: Persona Partial Knee system (Device)
Outcomes
Primary Outcomes
Oxford Knee Score
Time Frame: 10 years
A Patient reported functional outcome score for knee arthroplasty
Secondary Outcomes
- EQ-5D(10 years)