Burst Biologics Spinal Fusion Registry

Degenerative Disc Disease Clinical Trial

Official title:

Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Spinal Fusion Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064802
• Other study ID #: SP001
• Status: Recruiting
• Start date: March 24, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2019
• Source: Smart-Surgical Inc. dba Burst Biologics
• Contact: Steven M Czop, R.Ph.
• Phone: 888-322-1191
• Email: Sczop[@]smart-surgical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 surgeon and patient based outcome assessments.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: November 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Herniated Disk
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spinal Stenosis
• Spondylitis
• Spondylolisthesis

Intervention

Device:
• BioBurst Fluid, Burst Allograft
BioBurst Fluid or Burst Allograft used to augment spinal fusion

Locations

Country	Name	City	State
United States	OrthoBethesda	Bethesda	Maryland
United States	Carrollton Orthopaedic Clinic	Carrollton	Georgia
United States	Cary Orthopedics	Cary	North Carolina
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Burst Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Rate (%) . Number of patients fused/all patients operated (%)	Determined by CT Scan or Plain Radiographs	12 Months
Secondary	Visual Analog Scale (VAS)		12 Months
Secondary	Change from Baseline in Oswestry Disability Index (ODI)		12 months
Secondary	Change from Baseline in Short Form-12	SF12 Score	12 Months
Secondary	Change from Baseline in Neck Disability Index (NDI)	NDI Score	12 Months