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Burst Biologics Foot and Ankle Registry

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ClinicalTrials.gov Identifier: NCT03077256
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Burst Biologics, Smart-Surgical Inc. dba Burst Biologics

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.

Condition or disease Intervention/treatment
Foot and Ankle Disorders Ankle Fusion, Osteotomy Device: BioBurst Fluid, Burst Allograft

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health


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


Primary Outcome Measures :
  1. Fusion (%) Number of fusion patients fused/all fusion patients operated [ Time Frame: 6 Months ]
    Determined by CT Scan or Plain Radiographs

  2. Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated [ Time Frame: 6 Months ]
    Determined by CT Scan or Plain Radiographs


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 6 Months ]
  2. Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score [ Time Frame: 6 Months ]
  3. Change from Baseline in Foot Function Index Score (FFI) [ Time Frame: 6 Months ]
  4. Change from Baseline in Short Form-36 V2 [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077256


Contacts
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Contact: Steven M Czop, R.Ph. 888-322-1191 Sczop@smart-surgical.com

Locations
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United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Paul S Cooper, MD         
Sponsors and Collaborators
Burst Biologics
Investigators
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Study Director: Steven M Czop, R.Ph. Medical Affairs Officer

Additional Information:

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Responsible Party: Burst Biologics, Medical Affairs Officer, Smart-Surgical Inc. dba Burst Biologics
ClinicalTrials.gov Identifier: NCT03077256     History of Changes
Other Study ID Numbers: FA002
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burst Biologics, Smart-Surgical Inc. dba Burst Biologics:
Ankle Arthrodesis
Cellular Allograft