RadiculopathyNCT00437190
Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
A study testing ATLANTIS™ Cervical Plate System and allograft and BRYAN Cervical Disc Prosthesis in people with Radiculopathy and Myelopathy, run by Medtronic Spinal and Biologics at 38 sites in United States.
Trial summary
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Radiculopathy, Myelopathy, Cervical Degenerative Disc Disease
- What is being tested?
- ATLANTIS™ Cervical Plate System and allograft and BRYAN Cervical Disc Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 38 sitesUnited States
- Study dates
- Jun 2003to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
- The following additional inclusion criteria had to be present:
- At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
- Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
- Skeletally mature (≥ 21 years of age);
- Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
- Willing to sign informed consent and comply with protocol.
Who cannot join
- Subjects were excluded if they had any of the following:
- Any of the following at the treated level:
- Significant cervical anatomical deformity; e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
- Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;
- Radiographic signs of subluxation greater than 3.5 mm;
- Angulation of the disc space more than 11 degrees greater than adjacent segments;
Show all 20Show fewer
- Significant kyphotic deformity or significant reversal of lordosis;
- Axial neck pain as the solitary symptom;
- Previous cervical spine surgery;
- Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.5. If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.
- Active systemic infection or infection at the operative site;
- Known allergy or to titanium, polyurethane, or ethylene oxide residuals;
- Concomitant conditions requiring steroid treatment;
- Diabetes mellitus requiring daily insulin management;
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index;
- A medical condition that may interfere with the postoperative management program, such as advanced emphysema or Alzheimer's disease;
- A medical condition that may result in patient death prior to study completion: unstable cardiac disease, active malignancy;
- Pregnant;
- Current or recent alcohol and/or drug abuser requiring intervention;
- Signs of being geographically unstable, such as recent or pending divorce, or high level of job dissatisfaction.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Maryland Brain & Spine
Annapolis, Maryland, 21401
Emory Orthopedics and Spine Center
Atlanta, Georgia, 30329
Silicon Valley Spine Institute
Campbell, California, 95008
Carolina Neurosurgery and Spine Specialists
Charlotte, North Carolina, 28204
Northwestern University Department of Neurosurgery
Chicago, Illinois, 60611
University of Chicago Hospitals Section of Neurosurgery
Chicago, Illinois, 60637
Chicago Inst. of Neurosurgery and Neuro Research
Chicago, Illinois, 60640
Columbia Orthopaedic Group
Columbia, Missouri, 65201
Cervical Spine Specialists
Edina, Minnesota, 55439
North Florida Regional Medical Center
Gainesville, Florida, 32605
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Indiana Spine Group
Indianapolis, Indiana, 46260
Neurosurgery of Kalamazoo
Kalamazoo, Michigan, 49048
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin Medical School
Madison, Wisconsin, 53792
Marquette General Brain & Spine Center
Marquette, Michigan, 49855
University of Miami School of Medicine
Miami, Florida, 33136
Twin Cities Spine Center
Minneapolis, Minnesota, 55404
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464
Neurosurgical Associates
Nashville, Tennessee, 37203
Hoag Memorial Hospital
Newport Beach, California, 92663
Barrow Neurosurgical Associates
Phoenix, Arizona, 85013
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
NeuroSpine Consultants, PA
Plano, Texas, 75093
Kellogg MD Brain & Spine
Portland, Oregon, 97086
Spine Nevada
Reno, Nevada, 89502
Rochester Brain and Spine Neuro
Rochester, New York, 14623
Neurosurgery Associates
Salt Lake City, Utah, 84103
Neurosurgery Associates
Scarborough, Maine, 04074
Oregon Neurosurgery
Springfield, Oregon, 97477
Washington University Orthopedics
St Louis, Missouri, 63110
Upstate Orthopedics
Syracuse, New York, 13029
Crouse Hospital
Syracuse, New York, 13210
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
Neurosurgical Network, Inc.
Toledo, Ohio, 43608
Bay Area Spine Institute
Walnut Creek, California, 94598
Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.
Read the detailed description
Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.
- Being tested
- ATLANTIS™ Cervical Plate System and allograft, BRYAN Cervical Disc Prosthesis
- Keywords
- Cervical Disc Replacement, Spondylotic radiculopathy, Spondylotic myelopathy, Myelopathy, Radiculopathy
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLANTIS™ Cervical Plate System and allograftDevice
Also called cervical plate, plate, fusion, cervical fusion
Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
BRYAN Cervical Disc ProsthesisDevice
Also called disc, cervical disc, artificial disc, BRYAN
The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy Fusion | Active comparator | Not described Receives: Device: ATLANTIS™ Cervical Plate System and allograft |
| BRYAN Cervical Disc Prosthesis | Experimental | BRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit. Receives: Device: BRYAN Cervical Disc Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patient pain and ability to function
The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.
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 posted19 Feb 2007 (estimated)
- Study startJun 2003
- Primary completionDec 2006
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies 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
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rick C Sasso, MD, Principal investigator, Indiana Spine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437190
- Sponsor's protocol ID
- BRYAN(R) Cervical Disc IDE
- Status last verified
- May 2016
- First submitted
- 16 Feb 2007
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011 Sep 21;93(18):1684-92. doi: 10.2106/JBJS.J.00476.
PubMed 21938372Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). 2009 Jan 15;34(2):101-7. doi: 10.1097/BRS.0b013e31818ee263.
PubMed 19112337Arnold PM, Anderson KK, Selim A, Dryer RF, Kenneth Burkus J. Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2. J Neurosurg Spine. 2016 Sep;25(3):292-302. doi: 10.3171/2016.1.SPINE15798. Epub 2016 Apr 29.
PubMed 27129045
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00437190
- Acronym / sponsor ID
- BRYAN(R) Cervical Disc IDE
- Keywords
- Cervical Disc Replacement, Spondylotic radiculopathy, Spondylotic myelopathy, Myelopathy, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
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 this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.
Detailed description
Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.
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 Fusion | Active comparator | Device: ATLANTIS™ Cervical Plate System and allograft |
| BRYAN Cervical Disc Prosthesis | Experimental | Device: BRYAN Cervical Disc ProsthesisBRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
- At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
- Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
- Skeletally mature (≥ 21 years of age);
- Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
Key exclusion criteria (20 listed)
- Any of the following at the treated level:
- Axial neck pain as the solitary symptom;
- Previous cervical spine surgery;
- Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.5. If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.
- Active systemic infection or infection at the operative site;
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 |
|---|---|---|
| ATLANTIS™ Cervical Plate System and allograftAlso: cervical plate, plate, fusion, cervical fusionControl treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System. | Device | Anterior Cervical Discectomy Fusion |
| BRYAN Cervical Disc ProsthesisAlso: disc, cervical disc, artificial disc, BRYANThe intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit. | Device | BRYAN Cervical Disc Prosthesis |
Primary outcome
Improvement in patient pain and ability to function
Time frame: 24 months
The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 21938372Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011 Sep 21;93(18):1684-92. doi: 10.2106/JBJS.J.00476.
- Background: PubMed 19112337Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). 2009 Jan 15;34(2):101-7. doi: 10.1097/BRS.0b013e31818ee263.
- Derived from this study: PubMed 27129045Arnold PM, Anderson KK, Selim A, Dryer RF, Kenneth Burkus J. Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2. J Neurosurg Spine. 2016 Sep;25(3):292-302. doi: 10.3171/2016.1.SPINE15798. Epub 2016 Apr 29.
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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.
Rick C Sasso, MD principal investigator
Indiana Spine Group
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATLANTIS™ Cervical Plate System and allograft and BRYAN Cervical Disc Prosthesis in people with Radiculopathy and Myelopathy, run by Medtronic Spinal and Biologics at 38 sites in United States.
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 7 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: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in patient pain and ability to function (time frame: 24 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 NCT00437190, which also lists 3 linked publications.
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 13 May 2016.