Burst Biologics Foot and Ankle Registry

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 (Progenokine®) 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.

Inclusion Criteria:

- Patient aged 18 years or older

- Patient diagnosed with a pathology of the hindfoot, foot, or ankle requiring surgical
intervention.

- 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 the
surgeon's standard follow-up visits and clinical evaluations.

- Patient who has agreed to participate in the registry by providing consent per 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.