Burst Biologics Foot and Ankle Registry
Status unconfirmed
Conditions studied: Foot and Ankle Disorders, Ankle Fusion, Osteotomy
In brief
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.
Key facts
- Study ID
- NCT03077256
- Run by
- Burst Biologics
- People needed
- 300
- Starts
- 2017-03-24
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2019-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
Full record on ClinicalTrials.gov
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