Degenerative Disc DiseaseNCT01495234
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
A study testing rhBMP-2/BCP device in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics.
Trial summary
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring 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/BCP device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 1996to Jun 2001
- 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
- Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation >= 4mm or angulation >= 5°.
- Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
- Subject's pain is predominantly associated with the back.
- Subject has only one level involvement at L3-L4, L4-L5, or L5-S1.
- Subject is 18 years of age or greater at the time consent is given to participate in the study.
- Subject is willing to comply with the study plan and sign the informed consent.
- Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.
Who cannot join
- Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
- Subject has spinal stenosis or condition which requires a full laminectomy procedure.
- Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S1.
- Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
- Subject has overt or active infection near the operative spinal region.
- Subject has active systemic infection.
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- Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
- Subject 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/BCP implantation.
- The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.
- Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
- Subject has a known diagnosis of diabetes which requires treatment with medication.
- Subject has received previous radiation therapy at the site to be fused.
- Subject is unwilling to return for required follow-up visits.
- Subject is a prisoner.
- Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).
About this study
Official title: A Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.
- Conditions
- Degenerative Disc Disease
- Being tested
- rhBMP-2/BCP device
- Keywords
- Spinal degeneration
- 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/BCP deviceDevice
Also called Recombinant human bone morphogenetic protein-2
The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
rhBMP-2/BCP deviceDevice
Also called recombinant human Bone Morphogenetic Protein-2
The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Each patient will receive 15mg of rhBMP-2 in rhBMP-2/BCP device and implant unilaterally during a posterolateral spinal fusion procedure. The contralateral side was fused using standard fusion techniques with autograft bone. Receives: Device: rhBMP-2/BCP device |
| Cohort 2 | Experimental | Each patient will receive 20mg of rhBMP-2 in rhBMP-2/BCP device and implant bilaterally. Receives: Device: rhBMP-2/BCP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Status
Fusion will be met all of the following criteria:
- Evidence of bridging trabecular bone;
- Angular motion < 5°;
- Translational motion <= 3mm;
- No radiolucent lines spanning the entire fusion mass.
Measured: 12 month
Secondary outcomes (4)
Oswestry Low Back Pain Disability Questionnaire Status
Measured: 12 month
Neuro/Functional Status
A neurological functional questionnaire will be completed by patients prior to surgery and postoperative, including three questions pertaining to pain (severity of pain, location of pain, and leg pain side), and four questions associated with functional activities (recreational activity level, putting on shoes and socks, squatting, occupation activity level). Success will be based on a maintenance or improvement from the preoperative condition for the functional components, except that severity of pain success will be based on an improvement of at least one point on the five point scale.
Measured: 12 month
Neurological Status
A scale will be used to measure neurological status. This scale focuses on reflexes, sensory, motor function, and the degree of straight leg raise reproducing pain. All of these elements are combined to give an overall score. Success will be based on a maintenance or improvement in all categories from the preoperative condition.
Measured: 12 month
General Health Status (SF-36)
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 posted19 Dec 2011 (estimated)
- Study startOct 1996
- Primary completionJun 2001
- Study completionJun 2001
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT01495234
- Sponsor's protocol ID
- DOC#1187b BCP -Mexico
- 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 Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
- ClinicalTrials.gov ID
- NCT01495234
- Acronym / sponsor ID
- DOC#1187b BCP -Mexico
- Conditions
- Degenerative Disc Disease
- Keywords
- Spinal degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Oct 1996
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (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.
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: rhBMP-2/BCP deviceEach patient will receive 15mg of rhBMP-2 in rhBMP-2/BCP device and implant unilaterally during a posterolateral spinal fusion procedure. The contralateral side was fused using standard fusion techniques with autograft bone. |
| Cohort 2 | Experimental | Device: rhBMP-2/BCP deviceEach patient will receive 20mg of rhBMP-2 in rhBMP-2/BCP device and implant bilaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation >= 4mm or angulation >= 5°.
- Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
- Subject's pain is predominantly associated with the back.
- Subject has only one level involvement at L3-L4, L4-L5, or L5-S1.
- Subject is 18 years of age or greater at the time consent is given to participate in the study.
Key exclusion criteria (16 listed)
- Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
- Subject has spinal stenosis or condition which requires a full laminectomy procedure.
- Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S1.
- Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
- Subject has overt or active infection near the operative spinal region.
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/BCP deviceAlso: Recombinant human bone morphogenetic protein-2The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier. | Device | Cohort 1 |
| rhBMP-2/BCP deviceAlso: recombinant human Bone Morphogenetic Protein-2The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier. | Device | Cohort 2 |
Primary outcome
Fusion Status
Time frame: 12 month
Fusion will be met all of the following criteria: 1. Evidence of bridging trabecular bone; 2. Angular motion < 5°; 3. Translational motion <= 3mm; 4. No radiolucent lines spanning the entire fusion mass.
4 secondary outcomes
Oswestry Low Back Pain Disability Questionnaire Status
Time frame: 12 month
Neuro/Functional Status
Time frame: 12 month
Neurological Status
Time frame: 12 month
General Health Status (SF-36)
Time frame: 12 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 rhBMP-2/BCP device 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 7 inclusion and 16 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 Status (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 17 May 2023.