NL-OMON50496招募中不适用
Persona Netherlands Study - Persona Netherlands
Reinier Haga Orthopedisch Centrum0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is 18 to 75 years of age
- •2. Patient qualifies for a 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
- •e. The salvage of previously failed surgical attempts that did not include
- •partial or total knee arthroplasty of the ipsilateral knee
- •3. Patient is willing and able to provide written Informed Consent by signing
- •and dating the EC approved Informed Consent form
- •4. Patient is willing and able to complete scheduled study procedures and
- •follow-up evaluations 5. Independent of study participation, patient is a
- •candidate for commercially available Zimmer Persona knee implants implanted in
- •accordance with product labeling
排除标准
- •1. Patient is 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. Osteoporosis or 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. Patient has a known or suspected sensitivity or allergy to one or more of
- •the implant materials 11. Patient is pregnant or considered a member of a
- •protected population (e.g., prisoner, mentally incompetent, etc.)
- •12. Patient has previously received partial or total knee arthroplasty for the
- •ipsilateral knee.
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