Investigator-initiated, single-center prospective study on the clinical and radiological outcome after FENIX ® Facet Resurfacing Implant insertion in patients with chronic non-specific low back pain

AZ Nikolaas0 个研究点目标入组 10 人开始时间: 2019年3月19日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•1. Subject has a history of non-specific chronic low back pain (CLBP) for more than 6 months suggestive for facet joint syndrome” (See clinical diagnosis in Attachment 1)
•2. Subject age is between 20 and 70 years and is skeletally mature
•3. Failed conservative treatment for 3 months, including rehabilitation treatment, pharmacological and minimal interventional treatment.
•4. Positive diagnostic nerve block (See Section 10.3)
•5. Condition involves at least one lumbar spine level between contiguous levels L1 to S1.
•6. Back pain intensity of at least 5 on a scale of 10 (VAS).
•7. Oswestry score > 40 (based on 100-point scale)
•8. Pain frequency of at least 3 on a 5-point scale
•9. Radiology features suggestive for facet joint pathology. (See Section 10.2 for definitions) That is, the patient must have radiographic evidence of facet joint degeneration on Magnetic Resonance Imaging, classified as 1 or 2 on the Weishaupt scale and the SPECT-CT must show a hotspot level 2 at the facet joint, suspected to be the cause of low back pain

•1. Subject has any isthmic spondylolisthesis or degenerative spondylolisthesis >3mm detected on plain X-rays
•2. Subject has had prior spine surgery at the index level
•3. Subject has disc herniation that is not contained (3 or 4 on the Milette scale)
•4. Subject has central spinal canal stenosis
•5. Subject has Cauda Equina Syndrome
•6. Subject’s facet joints are absent or fractured.
•7. Subject is morbidly obese, having a Body Mass Index (BMI) of 35 or greater
•8. Kidney disease (serum creatinine >235 µmol)
•9. Subject has an active systemic infection or at the operative site
•10. Subject has a spinal tumor
•11. Subject has a known Chrome-Cobalt allergy.
•12. Subject is pregnant or plans to become pregnant during the study
•13. Subject is at high risk for evolution to chronicity (StarT back screening tool)

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