Cervical Degenerative Disc DiseasePhase 4NCT00700739
Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease
A Phase 4 study testing DISCOVER™ Artificial Cervical Disc and ACDF in people with Cervical Degenerative Disc Disease, run by DePuy International at 8 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- DISCOVER™ Artificial Cervical Disc and ACDF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 7 countries
- Study dates
- May 2008to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Australia2 sites
Westmead Private Hospital
Sydney, New South Wales
Calvary Hospital
Tasmania
About this study
Official 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
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.
Read the 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
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- DISCOVER™ Artificial Cervical Disc, ACDF
- Keywords
- Cervical, Disc, Arthroplasty, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISCOVER™ Artificial Cervical DiscDevice
DISCOVER™ Artificial Cervical Disc
ACDFDevice
Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Other | Anterior Cervical Discectomy and Fusion with Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft Receives: Device: ACDF |
| Cervical Total Disc Replacement | Active comparator | DISCOVER™ Artificial Cervical Disc Receives: Device: DISCOVER™ Artificial Cervical Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (15)
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.
Measured: 12 months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
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)
Measured: 12 months
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)
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 6 months
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.
Measured: 24 months
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).
Measured: 6 months
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).
Measured: 24 months
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.
Measured: 6 months
Device Related Adverse Events
The proportion of subjects with device related adverse events as reported throughout the duration of the study.
Measured: Intra-operatively to 24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: study progress and recruitment rate too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700739
- Sponsor's protocol ID
- CT 05/25
- Status last verified
- Sep 2015
- First submitted
- 18 Jun 2008
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 32049677
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00700739
- Acronym / sponsor ID
- CT 05/25
- Conditions
- Cervical Degenerative Disc Disease
- Keywords
- Cervical, Disc, Arthroplasty, Spinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study progress and recruitment rate too low
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Other | Device: ACDFAnterior Cervical Discectomy and Fusion with Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft |
| Cervical Total Disc Replacement | Active comparator | Device: DISCOVER™ Artificial Cervical DiscDISCOVER™ Artificial Cervical Disc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.)
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISCOVER™ Artificial Cervical DiscDISCOVER™ Artificial Cervical Disc | Device | Cervical Total Disc Replacement |
| ACDFCervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft | Device | Anterior Cervical Discectomy and Fusion (ACDF) |
Primary outcome
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.
15 secondary outcomes
Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months
Time frame: 12 months
Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.
Time frame: 12 Months
Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.
Time frame: 12 Months
Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.
Time frame: 12 Months
Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.
Time frame: 12 Months
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months
Time frame: 12 months
Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months
Time frame: 12 months
Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months
Time frame: 12 months
Work Status Assessed at 12 Months
Time frame: 12 months
Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months
Time frame: 6 months
Adjacent Level Degeneration Measured Radiographically at 24 Months
Time frame: 24 months
Maintenance of Disc Height Measured Radiographically at 6 Months
Time frame: 6 months
Foraminal Height Measured Radiographically at 24 Months
Time frame: 24 months
Cervical Range of Motion Measured Radiographically at 6 Months
Time frame: 6 months
Device Related Adverse Events
Time frame: Intra-operatively to 24 months post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32049677Salmons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DISCOVER™ Artificial Cervical Disc and ACDF in people with Cervical Degenerative Disc Disease, run by DePuy International at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Germany, Italy, Malaysia, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Patient Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00700739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.