on-interventional study (post-marketing clinical follow-up) of lumbar interbody fusion with an EndoLIF® Oblique Cage

joimax GmbH0 个研究点目标入组 52 人开始时间: 2015年2月10日最近更新: 2024年8月19日

适应症

试验速览

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•Patients for whom the clinical indications for implantation of an EndoLIF® O-Cage were the diagnosis of degenerative lumbar disc disease (M51.0 - M51.3) and spondylolisthesis (M43.16 or M43.17).
•Age 18 - 75 years

•Patients who are unable to give their consent due, e.g. to cognitive impairment.
•Active infection
•An allergy to titanium
•Patients with serious conditions (cancer, heart failure NYHA II or worse, diseases which irreversibly lead to stage ASA III and IV, drug or alcohol abuse, known severe blood clotting abnormalities, peripheral occlusive disease = stage IIb, severe polyneuropathy)
•No patient consent, particularly for patients who did not agree to a 24-month study follow-up
•Patients with fractures of the lumbar spine or in adjacent segments
•BMI > 40 kg/m2
•Soft tissue defects in the area of the planned surgical access route
•Serious diseases of the spine (e.g., osteoarthritis, osteopenia, osteoporosis or osteomalacia)
•Increased fracture risk (systemic or local)
•Diseases with a consecutively decreasing fusion rate
•Congenital malformations of the spine

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