Zimmer POLAR Persona - TKA (EMEA Study)

Launched by ZIMMER, GMBH · Jan 8, 2015

Keywords

ClinConnect Summary

The Zimmer POLAR Persona study is looking at how well a specific type of knee implant, known as the Persona knee implant, works for people who need a total knee replacement due to severe knee pain and disability caused by conditions like osteoarthritis or rheumatoid arthritis. The main goals of this study are to find out how long the implant lasts, how safe it is, and how it improves patients' overall pain, function, and quality of life.

To participate in this study, individuals must be between 18 and 75 years old and have a medical condition that qualifies them for a total knee replacement. This includes those with severe knee pain due to arthritis or other related issues. Participants will undergo scheduled procedures and follow-up evaluations to monitor their progress. It’s important to note that individuals with certain medical conditions, such as infections in the joint or insufficient bone structure, or those who have had previous knee surgeries on the same knee, will not be eligible for this trial.

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 is willing and able to complete scheduled study procedures and follow-up evaluations.
• • Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants 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.