Cervical Arthroplasty Study: Cadisc*-C Total Disc Replacement

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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.
11. Mild signs of myelopathy without change to the spinal cord as seen on T2-MRI

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
k. Instability of the cervical spine as defined radiographically (Panjabi & White [1990]), if suspected:
a. Flexion extension saggital plane translation >3.5mm or 20% and saggital plane rotation > 20°, OR
b. Resting X-rays: saggital plane displacement > 3.5mm or 20% and relative saggital plane angulation >11º
l. Myelopathy with change to the spinal cord as seen on T2-MRI
m. Morbid Obesity BMI>40
n. Unwillingness or inability to give consent or adhere to the follow-up programme
o. Drug or alcohol dependency
p. Currently involved in injury litigation
q. Known allergy to any of the implant materials
r. Subject has participated in another clinical investigation or study with an investigational medical device within the last 60 days
s. Concomitant medications that are known significantly to interfere with bone/soft tissue healing, e.g. steroids.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a composite of the proportion of subjects who show<br /><br>clinical success, where success is described by the following components:<br /><br>1. An improvement of 15 points on the arm VAS score at 3 months post-operatively<br /><br>2. An improvement of 15 points on the NDI scale at 3 months post-operatively,<br /><br>compared to baseline<br /><br>3. No significant adverse events<br /><br>A participant is defined as a success if:<br /><br>• 1 and 3 are true, or<br /><br>• 1 and 2 and 3 are true.</p><br>

Secondary Outcome Measures