Burst Biologics Spinal Fusion Registry

• Conditions: Spondylolisthesis; Spondylitis; Degenerative Disc Disease; Herniated Disk; Spinal Stenosis
• Interventions: Device: BioBurst Fluid, Burst Allograft

• Registration Number: NCT03064802
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-02-27
• Study Start: 2017-03-24
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2019-12-30
• Primary Completion: 2020-06-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BioBurst Fluid, Burst Allograft	BioBurst Fluid, Burst Allograft	Spinal Fusion with BioBurst Fluid or Burst Allograft

Primary Outcome Measures

Name	Time	Method
Fusion Rate (%) . Number of patients fused/all patients operated (%)	12 Months	Determined by CT Scan or Plain Radiographs

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Carrollton Orthopaedic Clinic; 🇺🇸 Carrollton, Georgia, United States

Orthopaedic Institute of Western Kentucky; 🇺🇸 Paducah, Kentucky, United States

OrthoBethesda; 🇺🇸 Bethesda, Maryland, United States

Cary Orthopedics; 🇺🇸 Cary, North Carolina, United States