Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Spinal Fusion Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 450
- Locations
- 4
- Primary Endpoint
- Fusion Rate (%) . Number of patients fused/all patients operated (%)
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Fusion Rate (%) . Number of patients fused/all patients operated (%)
Time Frame: 12 Months
Determined by CT Scan or Plain Radiographs
Secondary Outcomes
- Visual Analog Scale (VAS)(12 Months)
- Change from Baseline in Oswestry Disability Index (ODI)(12 months)
- Change from Baseline in Neck Disability Index (NDI)(12 Months)
- Change from Baseline in Short Form-12(12 Months)
Investigators
Burst Biologics
Medical Affairs Officer
Smart-Surgical Inc. dba Burst Biologics