Persona Partial Knee Clinical Outcomes Study

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.)