Clinical trial NCT03077256: Burst Biologics Foot and Ankle Registry
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Foot and Ankle Disorders
Ankle Fusion, Osteotomy
Keywords: Ankle Arthrodesis
Cellular Allograft
Lead sponsor: Smart-Surgical Inc. dba Burst Biologics
Sponsor class: INDUSTRY
First posted: 2017-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the study will be drawn from the individual surgeons practice. Patients will be either candidates for foot and ankle surgery after having failed conservative treatment or will have had foot and ankle surgery and the surgeon determined that the use of a Burst Biologic product is or was clinically indicated. Only patients who consent to participate and meet the inclusion-exclusion criteria will be included provided that a Burst Biologic product will be used in the surgery.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fusion (%) Number of fusion patients fused/all fusion patients operated
timeFrame: 6 Months
measure: Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated
timeFrame: 6 Months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 6 Months
measure: Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score
timeFrame: 6 Months
measure: Change from Baseline in Foot Function Index Score (FFI)
timeFrame: 6 Months
measure: Change from Baseline in Short Form-36 V2
timeFrame: 6 Months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Medical Affairs Officer
name: Steven M Czop, R.Ph.
role: STUDY_DIRECTOR
References: