Degenerative Disc DiseaseNCT03064802
Burst Biologics Spinal Fusion Registry
An observational study of Degenerative Disc Disease and Spinal Stenosis, run by Burst Biologics at 4 sites in United States.
Trial summary
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis
- What is being tested?
- BioBurst Fluid, Burst Allograft
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Mar 2017to 30 Nov 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: All patients in the study will be drawn from the individual surgeons practice. Patients will be either candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery and the surgeon determined that the use of a Burst Biologic product is or was clinically indicated.
Who may be able to join
- Patient aged 18 years or older
- Patient diagnosed with a degenerative spine disorder, has failed conservative treatment, and has decided to undergo surgery.
- The surgeon has determined that a Burst Biologic product is or was clinically indicated.
- Patient capable of understanding the content of the Informed Consent Form
- Patient willing and able to participate in the registry protocol including follow-up visits and clinical evaluations.
- Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.
Who cannot join
- The following are relative contraindications for the use of Burst Products, however the investigator surgeon is solely responsible for the determination of patient eligibility for surgery:
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative disease (other than degenerative disc disease)
- Hypercalcemia, abnormal calcium metabolism
- Existing acute or chronic infections, especially at the site of the operation
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- Inflammatory bone disease such as osteomyelitis
- Malignant tumors
- Patients who are or plan to become pregnant.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
OrthoBethesda
Bethesda, Maryland, 20817
Joseph O'Brien, MD
- Recruiting
Carrollton Orthopaedic Clinic
Carrollton, Georgia, 30117
Brad G Prybis, MD
- Recruiting
Cary Orthopedics
Cary, North Carolina, 27518
Sameer Mathur, MD
- Recruiting
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
K. Brandon Strenge, MD
About this study
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Spinal Fusion Surgery
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on surgeon and patient based outcome assessments.
Read the detailed description
Spinal fusion surgery remains the most common intervention despite the increasing prevalence of various motion preservation and alternative stabilization devices for patients who are unresponsive to conservative treatment and experience back and/or leg pain and decreased function/quality of life. Donor site morbidity and availability limit the use of autogenous bone and over the past two decades' surgeon interest in alternative bone grafts has steadily increased. Bone morphogenic proteins, synthetic bone graft substitutes, and various allograft products are widely available to surgeons. Limitations on the use of allografts in the past were mainly attributed to less than optimal donor screening and processing techniques which removed viable components needed to aid in the bone healing process.
In recent years, the focus and scientific advances in various allograft processing techniques have allowed the retention of various viable cytokines, growth factors, and cell populations which result in enhanced osteogenic and osteoinductive properties. Rigorous donor bone screening and meticulous testing has virtually eliminated the risk of disease transmission.
A unique proprietary cryoprotection processing technique for allograft tissue was developed by Smart-Surgical, Inc. and a complete line of allograft products was created and is now marketed by Burst Biologics (dba). In addition, rigorous standardized laboratory assay techniques and statistical analysis provide consistency and uniformity of the biologically active components of Burst allograft products.
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis, Herniated Disk
- Being tested
- BioBurst Fluid, Burst Allograft
- Keywords
- BioBurst, Spinal Fusion, Cellular Allograft
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylitis, Spondylolisthesis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBurst Fluid, Burst AllograftDevice
BioBurst Fluid or Burst Allograft used to augment spinal fusion
| Study group | Role | What they receive |
|---|---|---|
| BioBurst Fluid, Burst Allograft | Spinal Fusion with BioBurst Fluid or Burst Allograft Receives: Device: BioBurst Fluid, Burst Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rate (%) . Number of patients fused/all patients operated (%)
Determined by CT Scan or Plain Radiographs
Measured: 12 Months
Secondary outcomes (4)
Visual Analog Scale (VAS)
Measured: 12 Months
Change from Baseline in Oswestry Disability Index (ODI)
Measured: 12 months
Change from Baseline in Short Form-12
SF12 Score
Measured: 12 Months
Change from Baseline in Neck Disability Index (NDI)
NDI Score
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start24 Mar 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Burst Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Burst Biologics, Smart-Surgical Inc. dba Burst Biologics
- Investigators
- Steven M Czop, R.Ph., Study director, Medical Affairs Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064802
- Sponsor's protocol ID
- SP001
- Status last verified
- Dec 2019
- First submitted
- 13 Feb 2017
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT03064802
- Acronym / sponsor ID
- SP001
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis, Herniated Disk
- Keywords
- BioBurst, Spinal Fusion, Cellular Allograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Burst BiologicsIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 27 Feb 2017 (actual)
- 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.
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on surgeon and patient based outcome assessments.
Detailed description
Spinal fusion surgery remains the most common intervention despite the increasing prevalence of various motion preservation and alternative stabilization devices for patients who are unresponsive to conservative treatment and experience back and/or leg pain and decreased function/quality of life. Donor site morbidity and availability limit the use of autogenous bone and over the past two decades' surgeon interest in alternative bone grafts has steadily increased. Bone morphogenic proteins, synthetic bone graft substitutes, and various allograft products are widely available to surgeons. Limitations on the use of allografts in the past were mainly attributed to less than optimal donor screening and processing techniques which removed viable components needed to aid in the bone healing process.
In recent years, the focus and scientific advances in various allograft processing techniques have allowed the retention of various viable cytokines, growth factors, and cell populations which result in enhanced osteogenic and osteoinductive properties. Rigorous donor bone screening and meticulous testing has virtually eliminated the risk of disease transmission.
A unique proprietary cryoprotection processing technique for allograft tissue was developed by Smart-Surgical, Inc. and a complete line of allograft products was created and is now marketed by Burst Biologics (dba). In addition, rigorous standardized laboratory assay techniques and statistical analysis provide consistency and uniformity of the biologically active components of Burst allograft products.
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioBurst Fluid, Burst Allograft | – | Device: BioBurst Fluid, Burst AllograftSpinal Fusion with BioBurst Fluid or Burst Allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in the study will be drawn from the individual surgeons practice. Patients will be either candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery and the surgeon determined that the use of a Burst Biologic product is or was clinically indicated.
Key inclusion criteria (6 listed)
- Patient aged 18 years or older
- Patient diagnosed with a degenerative spine disorder, has failed conservative treatment, and has decided to undergo surgery.
- The surgeon has determined that a Burst Biologic product is or was clinically indicated.
- Patient capable of understanding the content of the Informed Consent Form
- Patient willing and able to participate in the registry protocol including follow-up visits and clinical evaluations.
Key exclusion criteria (9 listed)
- The following are relative contraindications for the use of Burst Products, however the investigator surgeon is solely responsible for the determination of patient eligibility for surgery:
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative disease (other than degenerative disc disease)
- Hypercalcemia, abnormal calcium metabolism
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 |
|---|---|---|
| BioBurst Fluid, Burst AllograftBioBurst Fluid or Burst Allograft used to augment spinal fusion | Device | BioBurst Fluid, Burst Allograft |
Primary outcome
Fusion Rate (%) . Number of patients fused/all patients operated (%)
Time frame: 12 Months
Determined by CT Scan or Plain Radiographs
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 12 Months
Change from Baseline in Oswestry Disability Index (ODI)
Time frame: 12 months
Change from Baseline in Short Form-12
Time frame: 12 Months
Change from Baseline in Neck Disability Index (NDI)
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Steven M Czop, R.Ph. study director
Medical Affairs Officer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spinal Stenosis, run by Burst Biologics at 4 sites in United States.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven M Czop, R.Ph. (888-322-1191, Sczop@smart-surgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Rate (%) . Number of patients fused/all patients operated (%) (time frame: 12 Months). 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 30 Dec 2019.