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Burst Biologics Spinal Fusion Registry

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ClinicalTrials.gov Identifier: NCT03064802
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Burst Biologics, Smart-Surgical Inc. dba Burst Biologics

Brief 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 surgeon and patient based outcome assessments.

Condition or disease Intervention/treatment
Degenerative Disc Disease Spinal Stenosis Spondylitis Spondylolisthesis Herniated Disk Device: BioBurst Fluid, Burst Allograft

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 450 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Spinal Fusion Surgery
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
BioBurst Fluid, Burst Allograft
Spinal Fusion with BioBurst Fluid or Burst Allograft
Device: BioBurst Fluid, Burst Allograft
BioBurst Fluid or Burst Allograft used to augment spinal fusion




Primary Outcome Measures :
  1. Fusion Rate (%) . Number of patients fused/all patients operated (%) [ Time Frame: 12 Months ]
    Determined by CT Scan or Plain Radiographs


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 12 Months ]
  2. Change from Baseline in Oswestry Disability Index (ODI) [ Time Frame: 12 months ]
  3. Change from Baseline in Short Form-12 [ Time Frame: 12 Months ]
    SF12 Score

  4. Change from Baseline in Neck Disability Index (NDI) [ Time Frame: 12 Months ]
    NDI Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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
  • Inflammatory bone disease such as osteomyelitis
  • Malignant tumors
  • Patients who are or plan to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064802


Contacts
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Contact: Steven M Czop, R.Ph. 888-322-1191 Sczop@smart-surgical.com

Locations
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United States, Georgia
Carrollton Orthopaedic Clinic Recruiting
Carrollton, Georgia, United States, 30117
Contact: Brad G Prybis, MD         
United States, Kentucky
Orthopaedic Institute of Western Kentucky Recruiting
Paducah, Kentucky, United States, 42001
Contact: Clint Hill, MD         
Orthopaedic Institute of Western Kentucky Recruiting
Paducah, Kentucky, United States, 42001
Contact: K. Brandon Strenge, MD         
United States, Maryland
OrthoBethesda Recruiting
Bethesda, Maryland, United States, 20817
Contact: Joseph O'Brien, MD         
United States, New York
New York Spine Care Recruiting
New York, New York, United States, 10010
Contact: Paul M Brisson, MD         
United States, North Carolina
Cary Orthopedics Recruiting
Cary, North Carolina, United States, 27518
Contact: Sameer Mathur, MD         
United States, Oklahoma
Oklahoma Spine and Brain Institute Recruiting
Tulsa, Oklahoma, United States, 74132
Contact: Frank J. Tomecek, MD         
Sponsors and Collaborators
Burst Biologics
Investigators
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Study Director: Steven M Czop, R.Ph. Medical Affairs Officer

Additional Information:

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Responsible Party: Burst Biologics, Medical Affairs Officer, Smart-Surgical Inc. dba Burst Biologics
ClinicalTrials.gov Identifier: NCT03064802     History of Changes
Other Study ID Numbers: SP001
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Burst Biologics, Smart-Surgical Inc. dba Burst Biologics:
BioBurst
Spinal Fusion
Cellular Allograft
Additional relevant MeSH terms:
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Spondylitis
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Intervertebral Disc Displacement
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Spondylosis
Hernia
Pathological Conditions, Anatomical