Degenerative Cervical Disc DiseaseNCT01491477
INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial
A study testing INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ and Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ in people with Degenerative Cervical Disc Disease, run by Medtronic Spinal and Biologics.
Trial summary
The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with cervical symptomatic degenerative disc disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Cervical Disc Disease
- What is being tested?
- INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ and Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Apr 2005
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
- herniated disc;
- osteophyte formation;
- decreased disc height;
- thickening of ligamentous tissue;
- disc degeneration; and/or
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- facet joint degeneration.
- Has preoperative Neck Disability Index score > 30;
- Has single cervical disc disease level requiring fusion from C2 to C7;
- No previous surgical intervention at the involved fusion level;
- Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
- Is at least 18 years of age, inclusive at time of surgery;
- If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery;
- Is willing and able to comply with study plan and sign the consent form.
Who cannot join
- Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged non-steroidal anti-inflammatory drugs excluding routine perioperative anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- Has been previously diagnosed with osteopenia, or osteomalacia.
- Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility).
- Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
- Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
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- Male over the age of 70.
- Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
- If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.
- Has presence of active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin.
- Has overt or active bacterial infection, either local or systemic.
- Has a documented titanium alloy allergy or intolerance.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Is a prisoner.
- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
- Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs.
- Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Has a history of exposure to injectable collagen implants.
- Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
- Has received any previous exposure to any/all BMP's of either human or animal extraction.
About this study
Official title: Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the Cornerstone-SR™ Allograft Ring and the ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with cervical symptomatic degenerative disc disease.
- Conditions
- Degenerative Cervical Disc Disease
- Being tested
- INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™, Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™Device
Also called Recombinant human bone morphogenetic protein-2
Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™Device
Also called Autograft
Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
| Study group | Role | What they receive |
|---|---|---|
| INFUSE™ Bone Graft | Experimental | Not described Receives: Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ |
| Autogenous bone | Active comparator | Not described Receives: Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success
A patient will be considered an overall success if all of the following conditions are met:
- fusion;
- pain/disability (Neck Disability Index) Improvement;
- maintenance or improvement in neurological status;
- no serious adverse event classified as "implant associated" or "implant/surgical procedure associated";
- no additional surgical procedure classified as a "failure".
Measured: 12 month
Secondary outcomes (5)
Disc Height Measurement
Measured: 12 month
General Health Status (SF-36)
Measured: 12 month
Pain Status (neck pain, arm pain)
Measured: 12 month
Patient Satisfaction
Measured: 12 month
Patient Global Perceived Effect
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startApr 2002
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical 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
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491477
- Sponsor's protocol ID
- P01-04
- Status last verified
- Dec 2011
- First submitted
- 12 Dec 2011
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the Cornerstone-SR™ Allograft Ring and the ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT01491477
- Acronym / sponsor ID
- P01-04
- Conditions
- Degenerative Cervical Disc Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 14 Dec 2011 (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 trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with cervical symptomatic degenerative disc disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INFUSE™ Bone Graft | Experimental | Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ |
| Autogenous bone | Active comparator | Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
- Has preoperative Neck Disability Index score > 30;
- Has single cervical disc disease level requiring fusion from C2 to C7;
- No previous surgical intervention at the involved fusion level;
- Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
Key exclusion criteria (21 listed)
- Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged non-steroidal anti-inflammatory drugs excluding routine perioperative anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- Has been previously diagnosed with osteopenia, or osteomalacia.
- Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility).
- If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.
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 |
|---|---|---|
| INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™Also: Recombinant human bone morphogenetic protein-2Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system. | Device | INFUSE™ Bone Graft |
| Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™Also: AutograftCornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system. | Device | Autogenous bone |
Primary outcome
Overall Success
Time frame: 12 month
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Neck Disability Index) Improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".
5 secondary outcomes
Disc Height Measurement
Time frame: 12 month
General Health Status (SF-36)
Time frame: 12 month
Pain Status (neck pain, arm pain)
Time frame: 12 month
Patient Satisfaction
Time frame: 12 month
Patient Global Perceived Effect
Time frame: 12 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ and Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ in people with Degenerative Cervical Disc Disease, run by Medtronic Spinal and Biologics.
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 14 inclusion and 21 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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: 12 month). 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 2 Aug 2013.