Recruiting

Observational Study

Sponsor:

Burst Biologics

Code:

NCT03077256

Conditions

Foot and Ankle Disorders

Ankle Fusion, Osteotomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BioBurst Fluid, Burst Allograft

Study Details

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

Study ID

NCT03077256

Start date

Mar 24, 2017

Status verified date

May, 2019

Completion date

Oct 1, 2020

Anticipated

Primary completion date

Jul 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

BioBurst Fluid, Burst Allograft

BioBurst Fluid, Burst Allograft in Foot and Ankle Surgery

Primary outcome measure

  • Fusion (%) Number of fusion patients fused/all fusion patients operated [ Time Frame: 6 Months ]
  • Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Steven M Czop, R.Ph.

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

Locations

Georgetown University Medical Center

Recruiting

Washington, District of Columbia, United States, 20007

More Information

Sponsor

Burst Biologics

Last update posted

May 28, 2019

Last verified

May, 2019

Keywords

  • Ankle Arthrodesis
  • Cellular Allograft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burst Biologics on 2019-05-28.