Degenerative Disc DiseaseNCT01494428
A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
A study testing rhBMP-2/ACS/allograft bone dowel and Autogenous bone/allograft bone dowel in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics.
Trial summary
The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- rhBMP-2/ACS/allograft bone dowel and Autogenous bone/allograft bone dowel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Feb 2004
- 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
- Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:
- instability( defined as angular motion > 5° and/or translation >= 2-4mm, based on Flex/Ext radiographs);
- osteophyte formation;
- decreased disc height;
- thickening of ligamentous tissue;
- disc degeneration or herniation; and/or
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- facet joint degeneration.
- Has preoperative Oswestry score > 35.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- Has single-level symptomatic degenerative involvement from L4 to S1.
- Is at least 18 years of age, inclusive, at the time of surgery.
- Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
- If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
- Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
Who cannot join
- Had previous anterior spinal fusion surgical procedure at the involved level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation).
- Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Has presence of active malignancy.
- Has overt or active bacterial infection, either local or systemic.
- Is obese, i.e., weight greater than 40% over ideal for their age and height.
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- Has fever (temperature> 101° F oral) at the time of surgery.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
- Is a prisoner.
- Is an alcohol and/or drug abuser.
- Is a tobacco user at the time of surgery.
- Patient 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).
- Patient has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Patient has a history of exposure to injectable collagen implants.
- Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- Patient 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.
- Patient has received any previous exposure to BMP.
- Patient has a history of severe allergy, an allergy to bovine products, or a history of anaphylaxis.
- Patient has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
About this study
Official title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
- Conditions
- Degenerative Disc Disease
- Being tested
- rhBMP-2/ACS/allograft bone dowel, Autogenous bone/allograft bone dowel
- Keywords
- symptomatic degenerative disc disease
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2/ACS/allograft bone dowelDevice
Also called Recombinant human bone morphogenetic protein-2
The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel.
Autogenous bone/allograft bone dowelDevice
Also called Autograft
An allograft bone dowel contains autogenous bone taken from the patient's iliac crest.
| Study group | Role | What they receive |
|---|---|---|
| rhBMP-2/ACS | Experimental | Not described Receives: Device: rhBMP-2/ACS/allograft bone dowel |
| Autogenous Bone | Active comparator | Not described Receives: Device: Autogenous bone/allograft bone dowel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and Rate of Implant-Associated Adverse Events
Measured: 24 month
Rate of Implant Revision, Removal and Supplemental Fixation Procedures
Measured: 24 month
Incidence of Permanent Adverse Events
Measured: 24 month
Fusion
Fusion is defined as:
- Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants.
- Angulation < 5°.
- Translation < 3mm.
- Absence of radiolucent lines around more than 50% of either implant.
Measured: 24 month
Disc Height Measurement
Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.
Measured: 24 month
Pain/Disability Status
The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success 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)
Nature and Frequency of Adverse Events Not Associated with the Implants
Measured: 24 month
Rate of Reoperation Procedures
Measured: 24 month
Hip (Donor Site) Pain Status
Measured: 24 month
Patient Satisfaction/Quality of Life Status (SF-36)
Measured: 24 month
Pain Status (Numerical Rating Scale)
Measured: 24 month
Overall Success
A patient will be considered an overall success if all of the following conditions are met:
- fusion
- disc height maintenance or improvement
- pain/disability (Oswestry) improvement
- maintenance or improvement in neurological status
- no permanent adverse event
- no additional surgical procedure classified as a "failure."
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 Dec 2011 (estimated)
- Study startApr 1998
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 46 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
- NCT01494428
- Sponsor's protocol ID
- C-9703
- 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
- A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT01494428
- Acronym / sponsor ID
- C-9703
- Conditions
- Degenerative Disc Disease
- Keywords
- symptomatic degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 19 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 pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBMP-2/ACS | Experimental | Device: rhBMP-2/ACS/allograft bone dowel |
| Autogenous Bone | Active comparator | Device: Autogenous bone/allograft bone dowel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:
- Has preoperative Oswestry score > 35.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- Has single-level symptomatic degenerative involvement from L4 to S1.
- Is at least 18 years of age, inclusive, at the time of surgery.
Key exclusion criteria (20 listed)
- Had previous anterior spinal fusion surgical procedure at the involved level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation).
- Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Has presence of active malignancy.
- Has overt or active bacterial infection, either local or systemic.
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 |
|---|---|---|
| rhBMP-2/ACS/allograft bone dowelAlso: Recombinant human bone morphogenetic protein-2The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel. | Device | rhBMP-2/ACS |
| Autogenous bone/allograft bone dowelAlso: AutograftAn allograft bone dowel contains autogenous bone taken from the patient's iliac crest. | Device | Autogenous Bone |
Primary outcome
Severity and Rate of Implant-Associated Adverse Events
Time frame: 24 month
Rate of Implant Revision, Removal and Supplemental Fixation Procedures
Time frame: 24 month
Incidence of Permanent Adverse Events
Time frame: 24 month
Fusion
Time frame: 24 month
Fusion is defined as: 1. Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants. 2. Angulation < 5°. 3. Translation < 3mm. 4. Absence of radiolucent lines around more than 50% of either implant.
Disc Height Measurement
Time frame: 24 month
Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.
Pain/Disability Status
Time frame: 24 month
The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success 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
Nature and Frequency of Adverse Events Not Associated with the Implants
Time frame: 24 month
Rate of Reoperation Procedures
Time frame: 24 month
Hip (Donor Site) Pain Status
Time frame: 24 month
Patient Satisfaction/Quality of Life Status (SF-36)
Time frame: 24 month
Pain Status (Numerical Rating Scale)
Time frame: 24 month
Overall Success
Time frame: 24 months
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 rhBMP-2/ACS/allograft bone dowel and Autogenous bone/allograft bone dowel in people with Degenerative 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 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 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?
Severity and Rate of Implant-Associated Adverse Events (time frame: 24 month). The study lists 7 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.