Burst Biologics Spinal Fusion Registry

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.

Study Overview

• Status: Unknown
• Conditions: Degenerative Disc Disease; Spondylitis; Spinal Stenosis; Spondylolisthesis; Herniated Disk
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Carrollton, Georgia, United States, 30117
      • Recruiting
      • Carrollton Orthopaedic Clinic
      • Contact: Brad G Prybis, MD
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Recruiting
      • Orthopaedic Institute of Western Kentucky
      • Contact: K. Brandon Strenge, MD
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • OrthoBethesda
      • Contact: Joseph O'Brien, MD
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Recruiting
      • Cary Orthopedics
      • Contact: Sameer Mathur, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Rate (%) . Number of patients fused/all patients operated (%)	Determined by CT Scan or Plain Radiographs	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)		12 Months
Change from Baseline in Oswestry Disability Index (ODI)		12 months
Change from Baseline in Short Form-12	SF12 Score	12 Months
Change from Baseline in Neck Disability Index (NDI)	NDI Score	12 Months

Collaborators and Investigators

• Sponsor: Burst Biologics
• Investigators: Study Director: Steven M Czop, R.Ph., Medical Affairs Officer

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2017
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): November 30, 2020

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (ACTUAL): February 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Spinal Fusion; BioBurst; Cellular Allograft
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Bone Diseases, Infectious; Spondylolysis; Spondylosis; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylitis; Spondylolisthesis
• Other Study ID Numbers: SP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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