Zimmer POLAR - Total Knee Arthroplasty (TKA)

Zimmer Biomet

Status

Completed

Conditions

Traumatic Arthritis

Osteoarthritis

RheumatoId Arthritis

Polyarthritis

Treatments

Device: Zimmer Persona Total Knee System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01859130

CSU2012-10K

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 measured by pain and function, quality of life data, radiographic parameters and survivorship.

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 Institutional Review Board (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, 4, and 5 years.

All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.

Enrollment

299 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:
- rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
- collagen disorders and/or avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus, or flexion deformities;
- 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 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.