Burst Biologics Spinal Fusion Registry

NCT03064802 | Unknown DMC

• 1 other identifier: SP001
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 4

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.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylitis; Spondylolisthesis; Herniated Disk

Keywords

BioBurst; Spinal Fusion; Cellular Allograft

Outcome Measures

Primary Outcomes (1)

• Fusion Rate (%) . Number of patients fused/all patients operated (%)

  Determined by CT Scan or Plain Radiographs

  12 Months

Secondary Outcomes (4)

• Visual Analog Scale (VAS)

  12 Months

• Change from Baseline in Oswestry Disability Index (ODI)

  12 months

• Change from Baseline in Short Form-12

  12 Months

• Change from Baseline in Neck Disability Index (NDI)

  12 Months

Study Arms (1)

BioBurst Fluid, Burst Allograft

Spinal Fusion with BioBurst Fluid or Burst Allograft

Device: BioBurst Fluid, Burst Allograft

Interventions

BioBurst Fluid, Burst Allograft DEVICE

BioBurst Fluid or Burst Allograft used to augment spinal fusion

BioBurst Fluid, Burst Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burst Biologics: lead

Study Sites (4)

Carrollton Orthopaedic Clinic

Carrollton, Georgia, 30117, United States

RECRUITING

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

RECRUITING

OrthoBethesda

Bethesda, Maryland, 20817, United States

RECRUITING

Cary Orthopedics

Cary, North Carolina, 27518, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylitis; Spondylolisthesis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Infectious; Infections; Spondylolysis; Spondylosis; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven M Czop, R.Ph.

  Medical Affairs Officer

  STUDY DIRECTOR

Central Study Contacts

Steven M Czop, R.Ph.

CONTACT

888-322-1191; Sczop@smart-surgical.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Affairs Officer

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 27, 2017
• Study Start: March 24, 2017
• Primary Completion: June 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)