Cervical degenerative disc disease
Conditions
Interventions
Subjects with cervical disease are currently treated with Anterior Cervical
Decompression and Fusion (ACDF) or cervical disc replacement. Cervical spinal
fusion is a surgery that joins selected bone
Sponsors
DePuy International Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria;i) Male or female subjects, aged between 18 and 65 years inclusive.;ii) Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.;iii) Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.;iv) Objective evidence of cervical disc disease in one vertebral level between C3-C7 defined as one or more of the following: * Shoulder and/or arm pain in a radicular distribution resulting from herniated disc or bony osteophytes (Consistent with diagnostic imaging including Axial CT, CT Myelogram, MRI and/or plain films) * Subjects with myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement;v) Unresponsive to documented non-surgical management for * 6 weeks and/or presents with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management (e.g., physical therapy, medication therapy, corticosteroid injections, etc.).;vi) Minimum Neck Disability Index score of *30 % (15/50 points)
Exclusion criteria
Exclusion criteria: Exclusion Criteria;i) Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.;ii) Subjects who are pregnant, lactating or wishes to become pregnant within the duration of the study.;iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.;iv) Subjects who have participated in a clinical investigation with an investigational product in the last 30 days.;v) Subjects who are currently involved in litigation and seeking permanent disability status for any injury to the spine (subjects involved in litigation and seeking reparation for lost wages, medical expenses can be included);vi) Subjects with significant degeneration at more than one cervical level (e.g. DISH, ankylosing spondylitis, congenital abnormality, rheumatoid arthritis);vii) Subjects who have had any prior surgery at the level to be treated (subjects with a prior Laminotomy at the level to be treated may be included in the study) viii) Subjects who have marked cervical instability on lateral or flexion/extension x-rays defined as translation *3mm and/or *11 degrees of rotational difference to either adjacent level;ix) Subjects who have presence of systemic infection or infection at the site of surgery;x) Any significant illness (e.g HIV or metastatic cancer of any type) that decreases the probability of the subject*s survival to the five-year follow up of the study. ;xi) Subjects who have been diagnosed with a condition or require postoperative medication(s) that may interfere with bony/soft tissue healing;xii) Subjects who have been diagnosed with Osteoporosis, Osteopenia, other metabolic bone disease or endocrine disorder known to affect osteogenesis. ;xiii) Subjects with pre-existing neurological abnormalities other than deficits produced from the spinal lesion (e.g., MS, Parkinson*s, CVA, diabetic neuropathy, peripheral neuropathy).;xiv) Subjects with morbid obesity defined as a BMI of *40 or more than 100 lbs (45.4kg) over ideal weight. (See Appendix II for BMI chart.);xv) Subjects with any known allergy to titanium metal, polyethylene xvi) Subjects who have had prior fusion surgery at any level(s) (C1-T1);xvii) Subjects with kyphosis >-15 degrees evaluated using the Cobb angle measurement;xviii) Subjects with Significant cervical degenerative disease characterized by bridging anterior osteophytes, significant loss of disc space height (3mm or less), sclerotic facets, large posterior osteophytes, autofusion of other cervical levels, and degenerative retrolisthesis. Spinal diseases such as DISH, ankylosing spondylitis, congenital abnormality, and rheumatoid arthritis, should also be excluded;xix) Subjects undergoing treatment with a bone growth stimulator, which cannot be discontinued prior to enrollment in the study.;xx) Significant kyphotic deformity or significant reversal of lordosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The primary endpoint is patient success as determined by clinical outcome measures. 1)Clinical Success requires a minimum of 15-point improvement in NDI, 2) no new clinically significant permanent abnormalities in neurological function (i.e., motor strength, nerve root tension signs, sensory and reflex signs), 3) no subsequent secondary surgical interventions at the index level, and no device-related serious adverse events (SAE) from baseline through 24-months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: * The change in pain relief assessed via Visual Analogue Scale (VAS) from pre-treatment for DISCOVER will be measured prior to discharge post op, 6 weeks, 6, 12, 24, 36, 48, and 60 months post op * The change in Quality of Life assessed by SF-36 from pre-treatment for DISCOVER will be measured at 12, 24, 36, 48, and 60 months post op * The change in function assessed by Neck Disability Index from pre-treatment for DISCOVER will be measured at 6 weeks, 6, 12, 24, 36, 48, and 60 months post op * The change in Neurological function assessed by motor strength, nerve root tension signs, sensory and reflex signs from pre-treatment for DISOVER will be measured prior to discharge, 6 weeks, 6, 12, 24, 36, 48, and 60 months post op * The work status of the subject will be assessed from pre-treatment for DISCOVER and measured at 6 weeks, 6, 12, 24, 36, 48, and 60 months post * The effect on sagittal angulation, measured by Radiographic Grade for DISCOVER will be measured at pre-treatment, prior to discharge post op, 6 weeks, 6, 12, 24, 36, 48, and 60 months post op * The effect on adjacent level degeneration measured by Radiographic Grade for DISCOVER will be measured at pre-treatment 24, 36, 48, and 60 months and compared with ACDF * The effect on maintenance of disc height measured by Radiographic Grade for DISCOVER will be measured at pre-treatment, prior to discharge post op, 6 weeks, 6, 12, 24, 36, 48, and 60 months * The effect on foraminal height measured by Radiographic Grade from pre-treatment for DISCOVER will be measured post-operatively 6 weeks, 12, 24, 36, 48, and 60 months * The effect on Cervical Range of Movement (CROM) measured by Radiographic Grade from pre-treatment for DISCOVER will be measured at 6 weeks, 6, 12, 24, 36, 48, and 60 months * The safety of the DISCOVER Artificial Cervical Disc by documenting the incidence of device-related serious adverse events and monitoring neurological function as measur | — |
Countries
Netherlands
Outcome results
None listed