Persona Total Knee Arthroplasty Outcomes Study

Zimmer Biomet

Status

Active, not recruiting

Conditions

Avascular Necrosis of the Femoral Condyle

Traumatic Arthritis

Osteoarthritis

Moderate Varus, Valgus or Flexion Deformities

Knee Pain Chronic

Polyarthritis

Rheumatoid Arthritis

Treatments

Device: Zimmer Persona Total Knee System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02255383

CSU2014-02K

Details and patient eligibility

About

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

Full description

The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. 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 total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a 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

737 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient 18-75 years of age, inclusive
Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
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 or 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 commercially available Persona fixed bearing knee components implanted in accordance with product labeling

Exclusion criteria

Patient is currently participating in any other surgical intervention studies or pain management studies
Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
Stable, painless arthrodesis in a satisfactory functional position
Severe instability secondary to the absence of collateral ligament integrity
Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Patient has previously received partial or total knee arthroplasty for the ipsilateral knee