Burst Biologics Foot and Ankle Registry
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|ClinicalTrials.gov Identifier: NCT03077256|
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : May 28, 2019
|Condition or disease||Intervention/treatment|
|Foot and Ankle Disorders Ankle Fusion, Osteotomy||Device: BioBurst Fluid, Burst Allograft|
Foot and ankle surgery requiring the use of bone graft is common despite recent advancements and improved outcomes with new motion preservation devices (ankle replacement). Autogenous bone remains the gold standard but is complicated by donor site morbidity and availability of a sufficient volume of graft. 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 foot and ankle surgeons performing procedures which involve bone grafting, as well as determining relevant patient outcomes.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery|
|Actual Study Start Date :||March 24, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
- Device: BioBurst Fluid, Burst Allograft
BioBurst Fluid, Burst Allograft in Foot and Ankle Surgery
- Fusion (%) Number of fusion patients fused/all fusion patients operated [ Time Frame: 6 Months ]Determined by CT Scan or Plain Radiographs
- Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated [ Time Frame: 6 Months ]Determined by CT Scan or Plain Radiographs
- Visual Analog Scale (VAS) [ Time Frame: 6 Months ]
- Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score [ Time Frame: 6 Months ]
- Change from Baseline in Foot Function Index Score (FFI) [ Time Frame: 6 Months ]
- Change from Baseline in Short Form-36 V2 [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077256
|Contact: Steven M Czop, R.Ph.||888-322-1191||Sczop@smart-surgical.com|
|United States, District of Columbia|
|Georgetown University Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Paul S Cooper, MD|
|Study Director:||Steven M Czop, R.Ph.||Medical Affairs Officer|