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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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.
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.
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.
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.
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
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
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
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Work Status Assessed at 12 Months
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Adjacent Level Degeneration Measured Radiographically at 24 Months
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Maintenance of Disc Height Measured Radiographically at 6 Months
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
Foraminal Height Measured Radiographically at 24 Months
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Cervical Range of Motion Measured Radiographically at 6 Months
Timepoint [14] 0 0
6 months
Secondary outcome [15] 0 0
Device Related Adverse Events
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
60
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/study/NCT00700739
Trial related presentations / publications
Salmons HI, Galetta MS, Divi SN, Fried TB, Fang T, Hoffman E, Goyal DKC, Mangan JJ, Schroeder GD, Vaccaro AR. Are Industry-funded Studies of Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion Biased? Clin Spine Surg. 2021 Feb 1;34(1):1-3. doi: 10.1097/BSD.0000000000000946. No abstract available.
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/study/NCT00700739