Burst Biologics Foot and Ankle Registry

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03077256
• Other study ID #: FA002
• Status: Recruiting
• Start date: March 24, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: May 2019
• Source: Smart-Surgical Inc. dba Burst Biologics
• Contact: Steven M Czop, R.Ph.
• Phone: 888-322-1191
• Email: Sczop[@]smart-surgical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Fusion, Osteotomy
• Foot and Ankle Disorders

Intervention

Device:
• BioBurst Fluid, Burst Allograft
BioBurst Fluid, Burst Allograft in Foot and Ankle Surgery

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Burst Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion (%) Number of fusion patients fused/all fusion patients operated	Determined by CT Scan or Plain Radiographs	6 Months
Primary	Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated	Determined by CT Scan or Plain Radiographs	6 Months
Secondary	Visual Analog Scale (VAS)		6 Months
Secondary	Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score		6 Months
Secondary	Change from Baseline in Foot Function Index Score (FFI)		6 Months
Secondary	Change from Baseline in Short Form-36 V2		6 Months