NL-OMON36805
Recruiting
Not Applicable
Cervical Arthroplasty Study: Cadisc*-C Total Disc Replacement - CASCADE
Clinical and Regulatory Affairs0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgical replacement of the cervical intervertebral discs (C3 to C7) for patients requiring surgical intervention for total cervical disc replacement for the treatment of discogenic pain (neck/shoulder/arm)
- Sponsor
- Clinical and Regulatory Affairs
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Skeletally mature patients (aged 18 years 65 years),
- •2\. Not pregnant or lactating at the time of surgery,
- •3\. Has cervical disc syndrome as defined as radiculopathy with or without accompanying cervical pain with symptomatic nerve root compression documented by patient history, clinical examination and confirmed by MRI or CT/myelogram, showing cervical disc herniation or nerve root entrapment
- •4\. One level cervical disc syndrome where the implantation may or may not be adjacent to a pre\-existent fusion
- •5\. Proposed surgical level at C3\- C7 inclusive,
- •6\. Unresponsive to conservative, i.e. non\-surgical management, such as pharmaceutical, physiotherapy or surgical micro\-discectomy/decompression for six weeks or presence of progressive symptoms or signs of cord compression,
- •7\. No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level other than outlined in inclusion criterion 4,
- •8\. Arm Pain score of \>\= 20 based on Visual Analogue Scale, may be with Preop Neck Disability index score \>\= 30
- •9\. Capable of and willing to comply to the study protocol in the opinion of the Investigator, including a is willingness to return to the hospital for all the required post\-operative follow\-up visits,
- •10\. Capable of and willing to provide voluntary, written informed consent to participate in this investigation and from whom written consent must be obtained prior to enrolment.
Exclusion Criteria
- •a. Arm pain confirmed as non discogenic in origin
- •b. Undergone previous cervical spinal surgery at the index level that could affect the trial outcome (e.g., disc replacement or previous fusion),
- •c. Radiographic evidence of facet degeneration or severe facet disease,
- •d. Active infection or metastatic, autoimmune or terminal disease
- •e. Osteoporosis, osteopenia or other metabolic bone disease or endocrine disorder known to affect osteogenesis,
- •f. Significant spinal deformity such as osteophytes, sclerotic facets,
- •g. Pre\-existing neurological abnormalities or other deficits, e.g. Parkinson\*s disease, diabetic neuropathy, MS, cerebro\-vascular accident, peripheral neuropathy,
- •h. Significant loss of disc height \>50%
- •i. Clinically compromised vertebral bodies at the affected level due to current or past trauma
- •j. Subject is skeletally immature as determined by the investigator
Outcomes
Primary Outcomes
Not specified
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