Clinical trial NCT03064802: Burst Biologics Spinal Fusion Registry
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Spinal Fusion Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Spinal Stenosis
Spondylitis
Spondylolisthesis
Herniated Disk
Keywords: BioBurst
Spinal Fusion
Cellular Allograft
Lead sponsor: Smart-Surgical Inc. dba Burst Biologics
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Fusion Rate (%) . Number of patients fused/all patients operated (%)
timeFrame: 12 Months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: Change from Baseline in Oswestry Disability Index (ODI)
timeFrame: 12 months
measure: Change from Baseline in Short Form-12
timeFrame: 12 Months
measure: Change from Baseline in Neck Disability Index (NDI)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Carrollton Orthopaedic Clinic
state: Georgia
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Bethesda
country: United States
facility: OrthoBethesda
state: Maryland
city: Cary
country: United States
facility: Cary Orthopedics
state: North Carolina
Study officials:
affiliation: Medical Affairs Officer
name: Steven M Czop, R.Ph.
role: STUDY_DIRECTOR
References: