Cervical Degenerative Disc DiseaseNCT00432159
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
A study testing Cervical TDR and ACDF with plate in people with Cervical Degenerative Disc Disease, run by DePuy Spine at 32 sites in 3 countries.
Trial summary
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- Cervical TDR and ACDF with plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 1 Jul 2006to 1 May 2016
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
- Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
- Moderate Neck Disability Index (NDI) score
- Able to give informed consent for study participation
- Able and willing to return for all follow-up visits
Who cannot join
- Significant cervical degenerative disc disease
- Prior fusion procedure at any level(s) (C1-T1)
- Marked cervical instability on lateral or flexion/extension radiographs
- Presence of systemic infection or infection at the surgical site
- Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- History of alcohol and/or drug abuse
Show all 9Show fewer
- Any known allergy to a metal alloy or polyethylene
- Morbid obesity
- Any significant general illness (e.g., metastatic cancer, HIV)
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
Johns Hopkins University
Baltimore, Maryland, 21210
Olympia Medical Center
Beverly Hills, California, 90211
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22903
Rush University/Midwest Orthopaedics
Chicago, Illinois, 60607
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
North Texas Spine Care at Baylor Health
Dallas, Texas, 75246
Triangle Orthopaedic Associates
Durham, North Carolina, 27704
Neurospine Institute
Eugene, Oregon, 97401
Southern NY Neurosurgical Group
Johnson City, New York, 13790
Borgess Medical Center
Kalamazoo, Michigan, 49048
Center for Diseases and Surgery of the Spine
Las Vegas, Nevada, 89106
University of Kentucky
Lexington, Kentucky, 40536
Rocky Mountain Associates in Orthopedic Medicine, PC
Loveland, Colorado, 80538
Twin Cities Spine
Minneapolis, Minnesota, 55404
St. Patrick Hospital Neurological Associates
Missoula, Montana, 59802
Yale University
New Haven, Connecticut, 06520
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07101
Boston Spine Group
Newton, Massachusetts, 02458
Nebraska Spine Center, LLC
Omaha, Nebraska, 68154
Johnson County Spine
Overland Park, Kansas, 66210
Texas Back Institute
Plano, Texas, 75093
William Beaumont Hospital
Royal Oak, Michigan, 48073
Sutter Medical Center
Sacramento, California, 95816
University of Utah
Salt Lake City, Utah, 84132
St. John's Regional Medical Center
Springfield, Missouri, 65804
Upstate Medical College/SUNY
Syracuse, New York, 13202
Florida Orthopaedic Institute
Tampa, Florida, 33607
About this study
Official title: A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.
Read the detailed description
This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Cervical TDR, ACDF with plate
- Keywords
- cervical, spinal, arthroplasty, disc, surgical, ACDF, DDD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical TDRDevice
Also called cervical arthroplasty, cervical disc, c-TDR, DISCOVER disc
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
ACDF with plateDevice
Also called ACDF, Slim-Loc, Anterior cervical discectomy and fusion with plate
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
| Study group | Role | What they receive |
|---|---|---|
| 1-level Cervical TDR | Experimental | Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Receives: Device: Cervical TDR |
| 1-level ACDF with plate | Active comparator | Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. Receives: Device: ACDF with plate |
| 2-level Cervical TDR | Experimental | Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Receives: Device: Cervical TDR |
| 2-level ACDF | Active comparator | Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. Receives: Device: ACDF with plate |
| Training: 1 & 2-level Cervical TDR | Experimental | Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Receives: Device: Cervical TDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
Measured: 24 months
Secondary outcomes (19)
NDI Success
15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Measured: 24 months
Neurological Component of Success
no new clinically significant permanent abnormalities in neurological function
Measured: 24 months
Subsequent Secondary Surgery Component of Success
no subsequent secondary surgical intervention at the index level
Measured: 24 months
Device-Related SAE Component of Success
no device related serious adverse events
Measured: 24 months
NDI - Change From Baseline
Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Measured: 24 months
Neck Pain VAS Scores - Change From Baseline
Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Measured: 24 months
Maximum Arm Pain VAS - Change From Baseline
Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Measured: 24 months
Average Arm Pain VAS - Change From Baseline
Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Measured: 24 months
Maximum Shoulder Pain VAS - Change From Baseline
Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Measured: 24 months
Average Shoulder Pain VAS - Change From Baseline
Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Measured: 24 months
Dysphagia Disability Index - Change From Baseline
Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
Measured: 24 months
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Measured: 24 months
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Measured: 24 months
Work Status Assessment
Measured: 24 months
Return to Work
Estimated Proportion of Subjects Returning to Work
Measured: 24 months
Activity
Clinical Assessment of Activity
Measured: 24 months
Subject Satisfaction
Subject Satisfaction (Would you have this procedure again?)
Measured: 24 months
Global Cervical Range of Motion - Change From Baseline
Measured: 24 months
Average Radiographic Disc Height (mm) - Change From Post-op
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study start1 Jul 2006
- Primary completion1 May 2013
- Study completion1 May 2016
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432159
- Sponsor's protocol ID
- 06-DISCOVER
- Status last verified
- Sep 2017
- First submitted
- 5 Feb 2007
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00432159
- Acronym / sponsor ID
- 06-DISCOVER
- Conditions
- Cervical Degenerative Disc Disease
- Keywords
- cervical, spinal, arthroplasty, disc, surgical, ACDF, DDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 7 Feb 2007 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.
Detailed description
This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1-level Cervical TDR | Experimental | Device: Cervical TDRCervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. |
| 1-level ACDF with plate | Active comparator | Device: ACDF with plateAnterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. |
| 2-level Cervical TDR | Experimental | Device: Cervical TDRCervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. |
| 2-level ACDF | Active comparator | Device: ACDF with plateAnterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. |
| Training: 1 & 2-level Cervical TDR | Experimental | Device: Cervical TDRCervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
- Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
- Moderate Neck Disability Index (NDI) score
- Able to give informed consent for study participation
- Able and willing to return for all follow-up visits
Key exclusion criteria (9 listed)
- Significant cervical degenerative disc disease
- Prior fusion procedure at any level(s) (C1-T1)
- Marked cervical instability on lateral or flexion/extension radiographs
- Presence of systemic infection or infection at the surgical site
- Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
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 |
|---|---|---|
| Cervical TDRAlso: cervical arthroplasty, cervical disc, c-TDR, DISCOVER discCervical total disc replacement using a DISCOVER Artificial Cervical Disc. | Device | 1-level Cervical TDR, 2-level Cervical TDR, Training: 1 & 2-level Cervical TDR |
| ACDF with plateAlso: ACDF, Slim-Loc, Anterior cervical discectomy and fusion with plateAnterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. | Device | 1-level ACDF with plate, 2-level ACDF |
Primary outcome
Overall Success
Time frame: 24 months
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
19 secondary outcomes
NDI Success
Time frame: 24 months
Neurological Component of Success
Time frame: 24 months
Subsequent Secondary Surgery Component of Success
Time frame: 24 months
Device-Related SAE Component of Success
Time frame: 24 months
NDI - Change From Baseline
Time frame: 24 months
Neck Pain VAS Scores - Change From Baseline
Time frame: 24 months
Maximum Arm Pain VAS - Change From Baseline
Time frame: 24 months
Average Arm Pain VAS - Change From Baseline
Time frame: 24 months
Maximum Shoulder Pain VAS - Change From Baseline
Time frame: 24 months
Average Shoulder Pain VAS - Change From Baseline
Time frame: 24 months
Dysphagia Disability Index - Change From Baseline
Time frame: 24 months
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Time frame: 24 months
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Time frame: 24 months
Work Status Assessment
Time frame: 24 months
Return to Work
Time frame: 24 months
Activity
Time frame: 24 months
Subject Satisfaction
Time frame: 24 months
Global Cervical Range of Motion - Change From Baseline
Time frame: 24 months
Average Radiographic Disc Height (mm) - Change From Post-op
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical TDR and ACDF with plate in people with Cervical Degenerative Disc Disease, run by DePuy Spine at 32 sites in 3 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Australia, Netherlands. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2014). 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 Success (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2017.