Safety and effectiveness of carbon fiber reinforced polyetheretherketone (CFR PEEK) implants in patients with bone tumors: an international multicenter retrospective registry

MC0 个研究点目标入组 1,100 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•In order to be eligible to participate in this registry, a patient must meet all of the following criteria. The patient:
•Is aged 18 years or older
•Has received or will receive a CFR PEEK implant
•Is diagnosed with either a primary bone tumor, metastatic bone lesion, soft-tissue sarcoma, benign bone tumor or multiple myeloma.

•A potential patient who meets any of the following criteria will be excluded from participation in this study:
•Metabolic bone disease
•History of Paget’s disease or other osteodystrophy’s whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, hyperparathyroidism, Ehrler’s- Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
•History of mental disorder or current psychiatric treatment.
•Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
•Lack of willingness to make a commitment to return for required follow-up visits.
•Drug and/or alcohol abuse

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