Prospective, Multi-centre Outcomes Study of Persona® Knee System in Total Knee Arthroplasty

Zimmer India Private Ltd0 个研究点目标入组 344 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•A patient must meet the following criteria to be eligible for participation:
•1. Age 18 to 80 years old, inclusive.
•2. Qualifies for a primary TKA 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.
•e) The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
•3. Participated in a study-related informed consent process.
•4. Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
•5. Willing and able to complete scheduled study procedures and follow-up
•evaluations.
•6. Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling.

•A patient must not meet the following criteria to be eligible for participation:
•1. Currently participating in any other surgical intervention studies or pain management studies
•2. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
•3. Insufficient bone stock on femoral or tibial surfaces.
•4. Skeletal immaturity.
•5. Neuropathic arthropathy.
•6. Any loss of musculature or neuromuscular disease that compromises the affected limb.
•7. Stable, painless arthrodesis in a satisfactory functional position.
•8. Severe instability secondary to the absence of collateral ligament integrity.
•9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
•10. Known or suspected sensitivity or allergy to one or more of the implant materials.

发起方

Zimmer India Private Ltd