NCT00700739TerminatedPhase 4
A Multi-Centre, Prospective, Randomized, Post Marketing Surveillance Study Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Cervical Degenerative Disc Disease
DePuy International8 sites in 7 countries60 target enrollmentStarted: May 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 8
- Primary Endpoint
- Overall Patient Success
Study Overview
Brief Summary
The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
Detailed Description
The protocol underwent 3 amendments, the last of which (02APR2009) changed the study design from a randomized to a non-randomized and non-comparative clinical trial. All of the subjects were enrolled under the randomized design with the exception of the last subject. This study is not applicable per FDAA Title VIII, Section 801 due to the final trial design. However, results are submitted to clinicaltrials.gov due to the majority of study data being collected under a randomized (FDAA Title VIII, Section 801 applicable) trial design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects, aged between 18 and 65 years inclusive.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •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.
- •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 w 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
- •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.)
- •Minimum Neck Disability Index score of ≥30 % (15/50 points)
Exclusion Criteria
- •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.
- •Subjects who are pregnant, lactating or wishes to become pregnant within the duration of the study.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical investigation with an investigational product in the last 30 days.
- •Subjects who are currently involved in any injury litigation claims.
- •Subjects with significant degeneration at more than one cervical level (e.g. DISH, ankylosing spondylitis, congenital abnormality, rheumatoid arthritis)
- •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)
- •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
- •Subjects who have presence of systemic infection or infection at the site of surgery
- •Subjects who have been diagnosed with malignancy
- •Subjects who have been diagnosed with a condition or require postoperative medication(s) that may interfere with bony/soft tissue healing
- •Subjects who have been diagnosed with Osteoporosis, Osteopenia, other metabolic bone disease or endocrine disorder known to affect osteogenesis.
- •Subjects with pre-existing neurological abnormalities other than deficits produced from the spinal lesion (e.g., MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy).
- •Subjects with morbid obesity defined as a BMI of ≥40, or more than 100 lbs (45.4kg) over ideal weight.
- •Subjects with any known allergy to titanium metal, polyethylene, metal alloy or carbon fibre reinforced polymer
- •Subjects who have had prior fusion surgery at any level(s) (C1-T1)
- •Subjects with kyphosis >-15 degrees evaluated using the Cobb angle measurement
- •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
- •Subjects undergoing treatment with a bone growth stimulator, which cannot be discontinued prior to enrollment in the study.
- •Significant kyphotic deformity or significant reversal of lordosis.
Outcomes
Primary Outcomes
Overall Patient Success
Time Frame: 12 months
Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.
Secondary Outcomes
- Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.(12 Months)
- Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.(12 Months)
- Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.(12 Months)
- Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months(12 months)
- Adjacent Level Degeneration Measured Radiographically at 24 Months(24 months)
- Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months(12 months)
- Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.(12 Months)
- Foraminal Height Measured Radiographically at 24 Months(24 months)
- Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months(12 months)
- Cervical Range of Motion Measured Radiographically at 6 Months(6 months)
- Device Related Adverse Events(Intra-operatively to 24 months post-operative)
- Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months(6 months)
- Maintenance of Disc Height Measured Radiographically at 6 Months(6 months)
- Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months(12 months)
- Work Status Assessed at 12 Months(12 months)
Investigators
Study Sites (8)
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