CTRI/2022/03/041158已完成4 期
Post Market Clinical Follow ? up study: A non-randomized, prospective to evaluate the Safety and Performance of Proximal Femoral Nail Anti-rotation (PFNA) intended for femur related fracture fixation. - PFNA
Auxein Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1] Subject is willing and able to give informed consent for participation in the study.
- •2] Male or Female, aged 18 years or above, skeletally mature patient.
- •3] Subject suffering from any of the following conditions: Comminuted fracture / Segmental fracture / Proximal and distal fracture / Non-unions / Sub-trochanteric fracture / Inter-trochanteric fracture.
- •4] Subject is willing and able to complete required study visits or assessments.
- •5]Participant has confirmed diagnosis as per the indications
排除标准
- •1. Isolated or combined medial femoral neck
- •2. Low sub-trochanteric fractures
- •3. Femoral shaft fractures
- •4. Isolated or combined medial femoral neck
- •5. Medial neck fracture
- •6. Signs of local inflammation
- •7. Infection local to the operative site
- •8. Fever or leukocytosis.
- •9. Neuromuscular disorders which can create
- •unacceptable risk of fixation failure or
- •complications in postoperative care.
- •10. Any other condition which would preclude the
- •potential benefit of implant insertion surgery and
- •disturb the normal process of bone remodeling, e.g. the presence of tumours or congenital
- •abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cells
- •(WBC) count, or a marked left shift in the WBC
- •differential count.
- •11. Suspected or documented allergy or intolerance to implant materials. Surgeon shall find out if the patient develops allergic reaction to the material of the implant (content of the implant material is presented in IMPLANT MATERIAL).
- •12. Any case not needing a surgical intervention.
- •13. Any case not described in the indications.
- •14. Any patient unwilling to cooperate with
- •postoperative instructions; mental illness, a
- •condition of senility or substance abuse may cause
- •the patient to ignore certain necessary limitations and precautions in the implant usage.
- •15. Any case where the implant components selected
- •for use would be too large or too small to achieve a successful result.
- •16. Any case that requires the simultaneous use of
- •elements from different systems that are made of
- •different metals.
- •17. Any case in which implant utilization would
- •disturb physiological processes.
- •18. Blood supply limitation in the operative site.
- •19. Morbid obesity (defined according to the WHO
- •standards).
- •20. Any case in which there is inadequate tissue
- •coverage of the operative site.
- •21. Shaft fractures with a fissure less than 5 cm from the nearest interlocking hole of the nail.
研究者
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