Degenerative Disc DiseaseNCT01494441
Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
A study testing rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System and Autograft/TSRH® Spinal System in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics.
Trial summary
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease. 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, rhBMP-2/BCP/TSRH® Spinal System and Autograft/TSRH® Spinal System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- May 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
- Has degenerative disc diseases 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 > 4 mm, 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 > 30.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932.).
- Requires fusion of a single level disc space from L1 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
- Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade1 or less spondylolisthesis at the involved level.
- Had previous spinal fusion surgical procedure at the involved level.
- Require spinal fusion at more than one lumbar level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Has presence of active malignancy.
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- Has overt or active bacterial infection, either local or systemic.
- Is grossly obese, i.e., weight > 40% over ideal for their age and height.
- Has fever ( temperature >101°F oral) at the time of surgery.
- Has a documented titanium alloy allergy or intolerance.
- 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 as defined by currently undergoing treatment for alcohol and/or drug usage.
- Is a tobacco user at the time of surgery.
- Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., NSAIDS, steroids or methotrexate).
- Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
- 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.
- Has received any previous exposure to any/all BMPs of either human or animal extraction.
- Has a history of severe allergy (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).
About this study
Official title: A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.
- Conditions
- Degenerative Disc Disease
- Being tested
- rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System, Autograft/TSRH® Spinal System
- Keywords
- lumbar 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/BCPProcedure or surgery
Also called recombinant human Bone Morphogenetic Protein-2, biphasic calcium phosphate
The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
rhBMP-2/BCP/TSRH® Spinal SystemDevice
Also called recombinant human Bone Morphogenetic Protein-2, biphasic calcium phosphate
rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.
Autograft/TSRH® Spinal SystemDevice
Also called Autograft
The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.
| Study group | Role | What they receive |
|---|---|---|
| rhBMP-2/BCP | Experimental | Not described Receives: Procedure: rhBMP-2/BCP |
| rhBMP-2/BCP/TSRH® Spinal System | Experimental | Not described Receives: Device: rhBMP-2/BCP/TSRH® Spinal System |
| Autograft/TSRH® Spinal System | Active comparator | Not described Receives: Device: Autograft/TSRH® Spinal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Fusion is defined as:
- Evidence of bridging trabecular bone.
- No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs;
- Absence of radiolucent lines completely through the fusion mass.
Measured: 24 month
Pain/Disability Status
The self-administered Oswestry Low Back pain Disability Questionnaire 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
Secondary outcomes (7)
Neurological Status Success
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes and straight leg raise.
Measured: 24 month
Hip (Donor Site) Pain
Measured: 24 month
General Health Status (SF-36)
Measured: 24 month
Pain Status (back pain, leg pain)
Measured: 24 month
Patient Satisfaction
Measured: 24 month
Patient Global Perceived Effect
Measured: 24 month
Overall Success
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 posted19 Dec 2011 (estimated)
- Study startMay 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 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
- 27 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
- NCT01494441
- Sponsor's protocol ID
- C-9805
- 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 Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT01494441
- Acronym / sponsor ID
- C-9805
- Conditions
- Degenerative Disc Disease
- Keywords
- lumbar degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- May 1999
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (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 both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rhBMP-2/BCP | Experimental | Procedure: rhBMP-2/BCP |
| rhBMP-2/BCP/TSRH® Spinal System | Experimental | Device: rhBMP-2/BCP/TSRH® Spinal System |
| Autograft/TSRH® Spinal System | Active comparator | Device: Autograft/TSRH® Spinal System |
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 diseases 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 > 30.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932.).
- Requires fusion of a single level disc space from L1 to S1.
- Is at least 18 years of age, inclusive, at the time of surgery.
Key exclusion criteria (22 listed)
- Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade1 or less spondylolisthesis at the involved level.
- Had previous spinal fusion surgical procedure at the involved level.
- Require spinal fusion at more than one lumbar level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
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/BCPAlso: recombinant human Bone Morphogenetic Protein-2, biphasic calcium phosphateThe rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier. | Procedure or surgery | rhBMP-2/BCP |
| rhBMP-2/BCP/TSRH® Spinal SystemAlso: recombinant human Bone Morphogenetic Protein-2, biphasic calcium phosphaterhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System. | Device | rhBMP-2/BCP/TSRH® Spinal System |
| Autograft/TSRH® Spinal SystemAlso: AutograftThe control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System. | Device | Autograft/TSRH® Spinal System |
Primary outcome
Fusion
Time frame: 24 month
Fusion is defined as: 1. Evidence of bridging trabecular bone. 2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs; 3. Absence of radiolucent lines completely through the fusion mass.
Pain/Disability Status
Time frame: 24 month
The self-administered Oswestry Low Back pain Disability Questionnaire 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
7 secondary outcomes
Neurological Status Success
Time frame: 24 month
Hip (Donor Site) Pain
Time frame: 24 month
General Health Status (SF-36)
Time frame: 24 month
Pain Status (back pain, leg pain)
Time frame: 24 month
Patient Satisfaction
Time frame: 24 month
Patient Global Perceived Effect
Time frame: 24 month
Overall Success
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 rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System and Autograft/TSRH® Spinal System 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 22 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 2 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.