Recruiting

Observational Study

Sponsor:

Burst Biologics

Code:

NCT03064802

Conditions

Degenerative Disc Disease

Spinal Stenosis

Spondylitis

Spondylolisthesis

Herniated Disk

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BioBurst Fluid, Burst Allograft

Study Details

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

Study ID

NCT03064802

Start date

Mar 24, 2017

Status verified date

Dec, 2019

Completion date

Nov 30, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

BioBurst Fluid, Burst Allograft

Spinal Fusion with BioBurst Fluid or Burst Allograft

Interventions

BioBurst Fluid, Burst Allograft

BioBurst Fluid or Burst Allograft used to augment spinal fusion

Primary outcome measure

  • Fusion Rate (%) . Number of patients fused/all patients operated (%) [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Steven M Czop, R.Ph.

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

Locations

Carrollton Orthopaedic Clinic

Recruiting

Carrollton, Georgia, United States, 30117

Orthopaedic Institute of Western Kentucky

Recruiting

Paducah, Kentucky, United States, 42001

OrthoBethesda

Recruiting

Bethesda, Maryland, United States, 20817

Cary Orthopedics

Recruiting

Cary, North Carolina, United States, 27518

More Information

Sponsor

Burst Biologics

Last update posted

Dec 30, 2019

Last verified

Dec, 2019

Keywords

  • BioBurst
  • Spinal Fusion
  • Cellular Allograft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burst Biologics on 2019-12-30.