Zimmer POLAR - Total Knee Arthroplasty (TKA)

Launched by ZIMMER BIOMET · May 16, 2013

Keywords

ClinConnect Summary

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 Sum...

Gender

ALL

Eligibility criteria

• 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.