Foot and Ankle Disorders Clinical Trial
Official title:
Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05401292 -
Skin Preparation for Elective Foot and Ankle Surgery
|
Phase 4 |