Foot and Ankle DisordersNCT03077256
Burst Biologics Foot and Ankle Registry
An observational study of Foot and Ankle Disorders and Ankle Fusion, Osteotomy, run by Burst Biologics at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot and Ankle Disorders, Ankle Fusion, Osteotomy
- What is being tested?
- BioBurst Fluid, Burst Allograft
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2017to 1 Oct 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Paul S Cooper, MD
About this study
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.
Read the 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.
- Conditions
- Foot and Ankle Disorders, Ankle Fusion, Osteotomy
- Being tested
- BioBurst Fluid, Burst Allograft
- Keywords
- Ankle Arthrodesis, Cellular Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBurst Fluid, Burst AllograftDevice
BioBurst Fluid, Burst Allograft in Foot and Ankle Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion (%) Number of fusion patients fused/all fusion patients operated
Determined by CT Scan or Plain Radiographs
Measured: 6 Months
Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated
Determined by CT Scan or Plain Radiographs
Measured: 6 Months
Secondary outcomes (4)
Visual Analog Scale (VAS)
Measured: 6 Months
Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score
Measured: 6 Months
Change from Baseline in Foot Function Index Score (FFI)
Measured: 6 Months
Change from Baseline in Short Form-36 V2
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start24 Mar 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot and Ankle DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Burst Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Burst Biologics, Smart-Surgical Inc. dba Burst Biologics
- Investigators
- Steven M Czop, R.Ph., Study director, Medical Affairs Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077256
- Sponsor's protocol ID
- FA002
- Status last verified
- May 2019
- First submitted
- 13 Feb 2017
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery
- ClinicalTrials.gov ID
- NCT03077256
- Acronym / sponsor ID
- FA002
- Conditions
- Foot and Ankle Disorders, Ankle Fusion, Osteotomy
- Keywords
- Ankle Arthrodesis, Cellular Allograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Burst BiologicsIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioBurst Fluid, Burst AllograftBioBurst Fluid, Burst Allograft in Foot and Ankle Surgery | Device | – |
Primary outcome
Fusion (%) Number of fusion patients fused/all fusion patients operated
Time frame: 6 Months
Determined by CT Scan or Plain Radiographs
Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated
Time frame: 6 Months
Determined by CT Scan or Plain Radiographs
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 6 Months
Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score
Time frame: 6 Months
Change from Baseline in Foot Function Index Score (FFI)
Time frame: 6 Months
Change from Baseline in Short Form-36 V2
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M Czop, R.Ph. study director
Medical Affairs Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot and Ankle Disorders and Ankle Fusion, Osteotomy, run by Burst Biologics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven M Czop, R.Ph. (888-322-1191, Sczop@smart-surgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (%) Number of fusion patients fused/all fusion patients operated (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.