An observational study in Degenerative Disc Disease, Spinal Stenosis and Spondylitis, sponsored by Burst Biologics. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-30.
Sponsored by Burst Biologics · Observational
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.
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 450 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Burst Biologics is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Spinal Fusion with BioBurst Fluid or Burst Allograft
Device: BioBurst Fluid, Burst Allograft
BioBurst Fluid or Burst Allograft used to augment spinal fusion
Fusion Rate (%) . Number of patients fused/all patients operated (%)
Determined by CT Scan or Plain Radiographs
Time frame: 12 Months
Visual Analog Scale (VAS)
Time frame: 12 Months
Change from Baseline in Oswestry Disability Index (ODI)
Time frame: 12 months
Change from Baseline in Short Form-12
SF12 Score
Time frame: 12 Months
Change from Baseline in Neck Disability Index (NDI)
NDI Score
Time frame: 12 Months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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