Degenerative Lumbar Disc DiseaseNCT00405600
Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone
A study testing Device used in surgery with or without instrumentation in people with Degenerative Lumbar Disc Disease and Spondylolisthesis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Degenerative Lumbar Disc Disease, Spondylolisthesis, Spinal Stenosis
- What is being tested?
- Device used in surgery with or without instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Dec 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient not currently participating in a drug or medical clinical trial.
- Patient signed informed consent.
- Patient is willing to be available for each examination scheduled over the study duration.
- Patient has clinical and radiologic history of degenerative disc disease or spondylolisthesis (no greater than grade 1 utilizing Meyerding's classification (Meyerding HW, 1932)); spinal stenosis for which conservative treatment has failed and lumbar spinal fusion is indicated.
- Eligible for non-instrumented or instrumented surgical procedure
- Has one or two levels (contiguous) involvement from L1-S1 requiring fusion
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- Has preoperative Oswestry score greater than 30
- Has not responded to non-operative treatment for a period of 6 months (bed rest, physical therapy, medication, manipulations, spinal injections, other).
- Is at least 20 years of age inclusive at the day of surgery
- If female of childbearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for one year following surgery.
Who cannot join
- Patient has a systemic infection.
- Patient has had more than one previous non-fusion spinal surgery at the involved level.
- Patient requires fusion at more than 2 levels.
- Patient has pseudoarthroses from a previous fusion attempt.
- Patient has highly communicable diseases, inflammatory or autoimmune disease (e.g.osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). A note to file written by the investigator will permit a patient into the study who experiences a mild case which will not affect the outcome of the study.
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
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- Patient has a significant medical history that, in the Investigator's opinion would not make them a good study candidate.
- Patient requires interbody cage fusion or non-pedicle screw instrumentation.
- Pregnancy.
- Has presence of active malignancy (except basal cell carcinoma of the skin)
- Has a history of severe allergy (anaphylaxis)
- Is grossly obese, i.e. weight over 40% over ideal for their height and age.
- Has a fever (temperature over 101 F oral)
- Has an allergy to the BMP-2
- Has allergy to bovine products
- Has an allergy to collagen implants
- Is mentally incompetent(if questionable, obtain psychiatric consult)
- Is a prisoner, a transient or have been treated in an inpatient substance abuse program for alcohol and/or drug abuse within six months prior to proposed study enrollment.
- Has received drugs which may interfere with bone metabolism within two weeks prior to the planned surgery
- Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,
Halifax, Nova Scotia, B3H-3A7
About this study
Official title: A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.
The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine.
In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.
Read the detailed description
In this study we will be using BMP-2 Infuse instead of the iliac crest bone graft for the spinal fusion. The BMP-2 Infuse has been researched in the only completed clinical trial for spinal fusions. It has demonstrated equivalence to the iliac crest bone graft with regard to both fusion rate and clinical outcome.
Currently, the acceptable standard of care for spinal fusion surgery requires instrumented or non-instrumented procedure with the use of bone graft materials, to facilitate bone growth, and a fusion, thus eliminating movement between the inciting vertebrae.
In this study, the surgical procedure will be BMP-2 Infuse with instrumentation or BMP-2 Infuse alone.
- Being tested
- Device used in surgery with or without instrumentation
- Keywords
- Lumbar degenerative disease, spinal stenosis, spondylolisthesis, non instrumented surgery, instrumented surgery, BMP-2
- Medical subject headings
- Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device used in surgery with or without instrumentationProcedure or surgery
Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.
| Study group | Role | What they receive |
|---|---|---|
| Device | Active comparator | Device used in surgery with or without instrumentation Receives: Procedure: Device used in surgery with or without instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate bone fusion;
Measured: 3mon., 6mon., 12mon., 24mon
Radiology tests; CT spine 24mon.
Measured: 3mon., 6mon., 12mon., 24mon
Clinical neurological evaluations; patient questionnaires
Measured: 3mon., 6mon., 12mon., 24mon
Secondary outcomes (2)
Hospital and surgical data
Measured: hospitalization;
Adverse events
Measured: hospitalization, clinic visits, unscheduled visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Alexander, Nova Scotia Health Authority
- Investigators
- Dr. David Alexander, M.D., Principal investigator, Capital Health District Authority, Centre for Clinical Research, Queen Elizabeth II, Health Sciences Centre, 1278 Tower Rd.,Halifax, Nova Scotia, B3H-9Z9, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405600
- Sponsor's protocol ID
- CDHA016
- Status last verified
- Feb 2013
- First submitted
- 28 Nov 2006
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.
- ClinicalTrials.gov ID
- NCT00405600
- Acronym / sponsor ID
- CDHA016
- Keywords
- Lumbar degenerative disease, spinal stenosis, spondylolisthesis, non instrumented surgery, instrumented surgery, BMP-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Nov 2006 (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 goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine.
In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.
Detailed description
In this study we will be using BMP-2 Infuse instead of the iliac crest bone graft for the spinal fusion. The BMP-2 Infuse has been researched in the only completed clinical trial for spinal fusions. It has demonstrated equivalence to the iliac crest bone graft with regard to both fusion rate and clinical outcome.
Currently, the acceptable standard of care for spinal fusion surgery requires instrumented or non-instrumented procedure with the use of bone graft materials, to facilitate bone growth, and a fusion, thus eliminating movement between the inciting vertebrae.
In this study, the surgical procedure will be BMP-2 Infuse with instrumentation or BMP-2 Infuse alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Active comparator | Procedure: Device used in surgery with or without instrumentationDevice used in surgery with or without instrumentation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient not currently participating in a drug or medical clinical trial.
- Patient signed informed consent.
- Patient is willing to be available for each examination scheduled over the study duration.
- Patient has clinical and radiologic history of degenerative disc disease or spondylolisthesis (no greater than grade 1 utilizing Meyerding's classification (Meyerding HW, 1932)); spinal stenosis for which conservative treatment has failed and lumbar spinal fusion is indicated.
- Eligible for non-instrumented or instrumented surgical procedure
Key exclusion criteria (21 listed)
- Patient has a systemic infection.
- Patient has had more than one previous non-fusion spinal surgery at the involved level.
- Patient requires fusion at more than 2 levels.
- Patient has pseudoarthroses from a previous fusion attempt.
- Patient has highly communicable diseases, inflammatory or autoimmune disease (e.g.osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). A note to file written by the investigator will permit a patient into the study who experiences a mild case which will not affect the outcome of 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 |
|---|---|---|
| Device used in surgery with or without instrumentationInfuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented. | Procedure or surgery | Device |
Primary outcome
To evaluate bone fusion;
Time frame: 3mon., 6mon., 12mon., 24mon
Radiology tests; CT spine 24mon.
Time frame: 3mon., 6mon., 12mon., 24mon
Clinical neurological evaluations; patient questionnaires
Time frame: 3mon., 6mon., 12mon., 24mon
2 secondary outcomes
Hospital and surgical data
Time frame: hospitalization;
Adverse events
Time frame: hospitalization, clinic visits, unscheduled visits
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 15 Feb 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.
Dr. David Alexander, M.D. principal investigator
Capital Health District Authority, Centre for Clinical Research, Queen Elizabeth II, Health Sciences Centre, 1278 Tower Rd.,Halifax, Nova Scotia, B3H-9Z9, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device used in surgery with or without instrumentation in people with Degenerative Lumbar Disc Disease and Spondylolisthesis, run by Nova Scotia Health Authority at 1 site in Canada.
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 10 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: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To evaluate bone fusion; (time frame: 3mon., 6mon., 12mon., 24mon). 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 15 Feb 2013.