Standard anterior cervical discectomy and fusion (ACDF) in patients with spine abrasion body
Conditions
Interventions
Group 1: Indication: Subjects, who in the surgeon’s opinion, are clinically indicated to have surgical treatment of anterior cervical discectomy and fusion (ACDF) with implantation of the BEE® HA Cage
Sponsors
Invibio Biomaterial Solutions
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 years of age or older (> 18 years) and are skeletally mature. 2. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery). 3. Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated. 4. Subjects who are indicated for surgical treatment with the BEE® HA Cage with In’Oss injectable bone substitute (Biomatlante Biologics Solutions). 5. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief. 6. Female subjects of childbearing age must have a negative pregnancy test, or must have a history of a surgical sterilisation, or must give history of no menses in the past twelve months. 7. Subjects who, in the opinion of the Investigator, are able to understand the nature, aims and possible consequences of the clinical study, co-operate with the procedures, and are willing to return to the clinic for all required post-operative follow-ups. 8. Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone previous spinal surgery either anterior or posterior. 2. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years. 3. Subjects with a known allergy to the material used in the instrumentation. 4. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study. 5. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator. 6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use. 7. Subjects who are receiving any drug treatment that may affect bone metabolism. 8. Female subjects who are pregnant or lactating. 9. Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes. 10. Subjects who are currently enrolled in a clinical study. 11. Subjects who are currently involved in any injury litigation claims. 12. Subjects who are kept in an institution under judicial or official orders or in a residential care institution or performing mandatory military service.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the reduction (improvement) in the Neck Disability Index at 12 months post-treatment. The mean percentage reduction will be compared to a literature-based performance goal of 13% as compared to pre-treatment scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical and patient outcomes will be evaluated at 6 weeks and 6, 12 and 24 months post-treatment: • To evaluate the clinical outcomes of pain (VAS neck and VAS arm), neurological function and pain medication (for cervical condition) use post-treatment compared to pre-treatment. • To evaluate patient quality of life outcomes post-treatment compared to pre-treatment. Quality of life will be assessed using the patient reported questionnaires SF-36, EQ-5D-5L and Neck Disability Index (NDI). • To evaluate patient satisfaction of the surgical treatment with the BEE® HA Cage including therapeutic goals. • To evaluate safety through the analysis of the incidence, severity, frequency and seriousness of any adverse events or adverse device effects (complications related to their cervical spinal surgery and cervical spine condition). • To evaluate the incidence of device deficiencies. • To evaluate the incidence of surgical interventions and non-surgical interventions. The radiological outcomes will be evaluated at post-surgery and 6 and 12 months post-treatment: • To evaluate mechanical function of the disc post-treatment from lateral/neutral radiographs including changes in the absolute disc height (mm), migration (mm) and subsidence (mm). • To evaluate mechanical function of the disc post-treatment from flexion/extension radiographs, at 6 and 12 months, including changes in translational AP-motion or instability (mm) and range of motion (o). • To evaluate the radiological outcomes of mean time to solid fusion and solid fusion rate at 6 and 12 months. Fusion assessment (from flexion/extension radiographs) is based on rotation <2o and <3 mm translation. • To evaluate the presence and extent of bony fusion from a CT scan acquired at 12 months (Site 3 only). Extent of bridging (CT) will be assessed in the sagittal and axial planes between the endplate and the BEE® HA Cage (defined as full/incomplete/no bridging). • To evaluate radiolucency around the BEE® | — |
Countries
Germany
Contacts
Public ContactStefan Bone
BG Klinikum Bergmannstrost
Outcome results
None listed