- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077256
Burst Biologics Foot and Ankle Registry
Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Steven M Czop, R.Ph.
- Phone Number: 888-322-1191
- Email: Sczop@smart-surgical.com
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Recruiting
- Georgetown University Medical Center
-
Contact:
- Paul S Cooper, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fusion (%) Number of fusion patients fused/all fusion patients operated
Time Frame: 6 Months
|
Determined by CT Scan or Plain Radiographs
|
6 Months
|
Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated
Time Frame: 6 Months
|
Determined by CT Scan or Plain Radiographs
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analog Scale (VAS)
Time Frame: 6 Months
|
6 Months
|
Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score
Time Frame: 6 Months
|
6 Months
|
Change from Baseline in Foot Function Index Score (FFI)
Time Frame: 6 Months
|
6 Months
|
Change from Baseline in Short Form-36 V2
Time Frame: 6 Months
|
6 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steven M Czop, R.Ph., Medical Affairs Officer
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FA002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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