Degenerative Cervical Disc DiseaseNCT01491399
INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study
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 clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 33 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to Mar 2003
- 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 years and older
- 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;
- C2-C3 disc to C7-Tl disc level(s) of involvement.
- One or two adjacent levels requiring fusion;
- No previous surgical intervention at the involved fusion level(s);
- 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;
- Age > 18 years at time of surgery;
- Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;
- Willingness 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(s).
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
- Has presence of spinal metastases.
- Has overt or active bacterial infection, either local or systemic.
- Has fever (temperature > 101°F oral) at the time of surgery.
- Has a documented titanium alloy allergy or intolerance.
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- 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.
- Has a history of allergy to bovine products or a history of anaphylaxis.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids, excluding routine perioperative anti-inflammatory drugs.
About this study
Official title: Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the CORNERSTONE-SR™Allograft Ring and ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
The purpose of this clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of 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, Infuse
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/CORNERSTONE-SR™ | Experimental | Not described Receives: Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ |
| Autogenous bone/CORNERSTONE-SR™ | 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.
Fusion
Fusion is defined as:
- No evidence of motion as defined by: less than 4° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs.
- No radiolucency greater than 2mm of thickness covering more than 50% of superior or inferior graft surface.
- Evidence of bridging trabecular bone.
Measured: 24 month
Pain/Disability Status
The self-administered Neck Disability Index will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
Measured: 24 month
Neurological Status
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Measured: 24 month
Secondary outcomes (6)
Time to fusion
Measured: 24 month
Hip (Donor Site) Pain
Measured: 24 month
General Health Status (SF-36)
Measured: 24 month
Pain Status (neck pain, arm pain)
Measured: 24 month
Patient Satisfaction
Measured: 24 month
Patient Global Perceived Effect
Measured: 24 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 startSep 1999
- Primary completionMar 2003
- Study completionMar 2003
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
- 33 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
- NCT01491399
- Sponsor's protocol ID
- C-9702 Cornerstone ACDF pilot
- Status last verified
- May 2023
- First submitted
- 12 Dec 2011
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. 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 ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT01491399
- Acronym / sponsor ID
- C-9702 Cornerstone ACDF pilot
- Conditions
- Degenerative Cervical Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (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 clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of 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/CORNERSTONE-SR™ | Experimental | Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ |
| Autogenous bone/CORNERSTONE-SR™ | Active comparator | Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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;
- C2-C3 disc to C7-Tl disc level(s) of involvement.
- One or two adjacent levels requiring fusion;
- No previous surgical intervention at the involved fusion level(s);
Key exclusion criteria (18 listed)
- Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
- Has presence of spinal metastases.
- Has overt or active bacterial infection, either local or systemic.
- Has fever (temperature > 101°F oral) at the time of surgery.
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-2, InfuseCornerstone-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/CORNERSTONE-SR™ |
| 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/CORNERSTONE-SR™ |
Primary outcome
Fusion
Time frame: 24 month
Fusion is defined as: * No evidence of motion as defined by: less than 4° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs. * No radiolucency greater than 2mm of thickness covering more than 50% of superior or inferior graft surface. * Evidence of bridging trabecular bone.
Pain/Disability Status
Time frame: 24 month
The self-administered Neck Disability Index will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
Neurological Status
Time frame: 24 month
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
6 secondary outcomes
Time to fusion
Time frame: 24 month
Hip (Donor Site) Pain
Time frame: 24 month
General Health Status (SF-36)
Time frame: 24 month
Pain Status (neck pain, arm pain)
Time frame: 24 month
Patient Satisfaction
Time frame: 24 month
Patient Global Perceived Effect
Time frame: 24 month
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 17 May 2023.
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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 15 inclusion and 18 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 17 May 2023. 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 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?
Fusion (time frame: 24 month). The study lists 3 primary outcomes in all. 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 17 May 2023.