Post-market clinical follow-up study with the cyclOS Putty

Mathys AG Bettlach0 个研究点目标入组 17 人开始时间: 2022年10月24日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•o Age between 18 and 70 years at inclusion
•o Patients who need surgical treatment with TLIF at 1 or 2 adjacent levels between L3 and S1 due to chronic degenerative disease of the lumbar spine
•o The patient has given his/her written consent to participate after having been fully informed (informed consent of the patient)
•o The patient is willing to participate in the follow-up examinations mentioned

•o Minors (< 18 years) at inclusion
•o Patients with age >70 at inclusion
•o Pregnant or breastfeeding women
•o Prisoners at inclusion
•o Incapacitated subjects (individuals who are not able to give informed consent due to a mental disability)
•o Patient considered particularly vulnerable to substances and/or materials used in the study
•o Patients in emergency situations preventing the patient from giving informed consent
•o Enrolment of the investigator, his/her family, employees (Mathys Ltd Bettlach / investigational site) and other prejudiced persons
•o Known or suspected non-compliance of eligibility criteria (e.g., drug or alcohol abuse)
•o Non-compliance with clinical investigation-related processes (such as diagnosis and therapy)
•o Current therapies using steroids and drugs that intervene in the calcium metabolism
•o Previous surgery on the same or adjacent level
•o Infection of the lumbar spine, past or present tumor of the lumbar spine, significant bony defect in the lumbar spine, or scoliosis
•o Diseases that significantly inhibit bone healing: osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease or renal insufficiency
•o Contraindications set out in the instruction for use (IFU)

发起方