Burst Biologics Spinal Fusion Registry

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03064802
Study type	Observational [Patient Registry]
Source	Smart-Surgical Inc. dba Burst Biologics
Contact	Steven M Czop, R.Ph.
Phone	888-322-1191
Email	Sczop@smart-surgical.com
Status	Recruiting
Phase
Start date	March 24, 2017
Completion date	November 30, 2020

View Details

See also
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Recruiting	`NCT04469387` - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.