Burst Biologics Spinal Fusion Registry
Status unconfirmed
Conditions studied: Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis, Herniated Disk
In brief
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on surgeon and patient based outcome assessments.
Key facts
- Study ID
- NCT03064802
- Run by
- Burst Biologics
- People needed
- 450
- Starts
- 2017-03-24
- Expected to finish
- 2020-11-30
- Last updated by the study team
- 2019-12-30
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 degenerative spine disorder, has failed conservative treatment, and has decided to undergo surgery.
- 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 follow-up visits and clinical evaluations.
- Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.
You may not qualify if…
- 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
- Carrollton Orthopaedic Clinic — Carrollton, Georgia, United States (enrolling)
- Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States (enrolling)
- OrthoBethesda — Bethesda, Maryland, United States (enrolling)
- Cary Orthopedics — Cary, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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