Burst Biologics Spinal Fusion Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03064802
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Burst Biologics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven M Czop, R.Ph.
Principal Investigator Affiliation Medical Affairs Officer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis, Herniated Disk
Additional Details

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.

Arms & Interventions

Arms

: BioBurst Fluid, Burst Allograft

Spinal Fusion with BioBurst Fluid or Burst Allograft

Interventions

Device: - BioBurst Fluid, Burst Allograft

BioBurst Fluid or Burst Allograft used to augment spinal fusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Carrollton Orthopaedic Clinic, Carrollton, Georgia

Status

Recruiting

Address

Carrollton Orthopaedic Clinic

Carrollton, Georgia, 30117

Site Contact

Brad G Prybis, MD

[email protected]

888-322-1191

Paducah, Kentucky

Status

Recruiting

Address

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001

Site Contact

K. Brandon Strenge, MD

[email protected]

888-322-1191

OrthoBethesda, Bethesda, Maryland

Status

Recruiting

Address

OrthoBethesda

Bethesda, Maryland, 20817

Site Contact

Joseph O'Brien, MD

[email protected]

888-322-1191

Cary Orthopedics, Cary, North Carolina

Status

Recruiting

Address

Cary Orthopedics

Cary, North Carolina, 27518

Site Contact

Sameer Mathur, MD

[email protected]

888-322-1191