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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00700739




Registration number
NCT00700739
Ethics application status
Date submitted
18/06/2008
Date registered
19/06/2008
Date last updated
21/09/2015

Titles & IDs
Public title
Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease
Scientific title
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
Secondary ID [1] 0 0
CT 05/25
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Degenerative Disc Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - DISCOVER™ Artificial Cervical Disc
Treatment: Devices - ACDF

Other: Anterior Cervical Discectomy and Fusion (ACDF) - Anterior Cervical Discectomy and Fusion with Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft

Active Comparator: Cervical Total Disc Replacement - DISCOVER™ Artificial Cervical Disc


Treatment: Devices: DISCOVER™ Artificial Cervical Disc
DISCOVER™ Artificial Cervical Disc

Treatment: Devices: ACDF
Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Patient Success - 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.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months - The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months. - The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months. - The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months. - The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months. - The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.
Timepoint [5] 0 0
12 Months
Secondary outcome [6] 0 0
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months - The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months - The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months - The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Work Status Assessed at 12 Months - The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months - Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Adjacent Level Degeneration Measured Radiographically at 24 Months - Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Maintenance of Disc Height Measured Radiographically at 6 Months - Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
Foraminal Height Measured Radiographically at 24 Months - Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Cervical Range of Motion Measured Radiographically at 6 Months - Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.
Timepoint [14] 0 0
6 months
Secondary outcome [15] 0 0
Device Related Adverse Events - The proportion of subjects with device related adverse events as reported throughout the duration of the study.
Timepoint [15] 0 0
Intra-operatively to 24 months post-operative

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Private Hospital - Sydney
Recruitment hospital [2] 0 0
Calvary Hospital - Tasmania
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Tasmania
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Holstein
Country [2] 0 0
Italy
State/province [2] 0 0
Rome
Country [3] 0 0
Malaysia
State/province [3] 0 0
Penang
Country [4] 0 0
Netherlands
State/province [4] 0 0
Tilburg
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Lancashire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00700739
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00700739