Burst Biologics Foot and Ankle Registry

NCT03077256 | Unknown DMC

• 1 other identifier: FA002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot and Ankle Disorders; Ankle Fusion, Osteotomy

Keywords

Ankle Arthrodesis; Cellular Allograft

Outcome Measures

Primary Outcomes (2)

• Fusion (%) Number of fusion patients fused/all fusion patients operated

  Determined by CT Scan or Plain Radiographs

  6 Months

• Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated

  Determined by CT Scan or Plain Radiographs

  6 Months

Secondary Outcomes (4)

• Visual Analog Scale (VAS)

  6 Months

• Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score

  6 Months

• Change from Baseline in Foot Function Index Score (FFI)

  6 Months

• Change from Baseline in Short Form-36 V2

  6 Months

Interventions

BioBurst Fluid, Burst Allograft DEVICE

BioBurst Fluid, Burst Allograft in Foot and Ankle Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burst Biologics: lead

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Study Officials

• Steven M Czop, R.Ph.

  Medical Affairs Officer

  STUDY DIRECTOR

Central Study Contacts

Steven M Czop, R.Ph.

CONTACT

888-322-1191; Sczop@smart-surgical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Affairs Officer

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 10, 2017
• Study Start: March 24, 2017
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)