Phase
Condition
Holoprosencephaly
Spine Athroplasty
Birth Defects
Treatment
iFuse Bedrock Granite Implant System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥ 18 years of age at screening.
Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuseBedrock Granite
Patient is willing and able to provide written informed consent
Exclusion
Exclusion Criteria:
Any known anatomic issues or permanent implants already in the pelvis that couldinterfere with placement of the study device(s)
Prominent neurologic or uncontrolled psychiatric condition that would interfere withstudy participation
Known allergy to titanium or titanium alloys
Current local or systemic infection that raises the risk of surgery
Currently pregnant or planning pregnancy in the next 2 years
Known or suspected active drug or alcohol abuse, including opioids
Patient is a prisoner or ward of the state
Patient is enrolled in an investigational clinical trial related to the spine
Study Design
Study Description
Connect with a study center
USA Neurosurgery
Mobile, Alabama 36688
United StatesActive - Recruiting
University of Colorado School of Medicine
Aurora, Colorado 80045
United StatesActive - Recruiting
Corewell Health
Royal Oak, Michigan 48073
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55454
United StatesActive - Recruiting
University at Buffalo
Buffalo, New York 14203
United StatesActive - Recruiting
Northwell Health
New York, New York 10075
United StatesActive - Recruiting
Pinehurst Surgical Clinic
Pinehurst, North Carolina 28374
United StatesActive - Recruiting
Texas Back Institute
Plano, Texas 75093
United StatesActive - Recruiting
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