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The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
Full description
This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.
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Inclusion criteria
Exclusion criteria
Indication for multilevel spine fusion surgery is any of the following:
Prior sacroiliac joint fusion/fixation on either side
Presence of spinal cord stimulator
Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
Surgeon plans to use iliac screw for pelvic fixation
Any known sacral or iliac pathology
Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
Known metabolic bone disease
Severe osteoporosis
Known allergy to titanium or titanium alloys
Use of medications known to have detrimental effects on bone quality and soft-tissue healing
Neurologic condition that would interfere with postoperative physical therapy
Current local or systemic infection that raises the risk of surgery
Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain.
Currently pregnant or planning pregnancy in the next 2 years
Prisoner or a ward of the state.
Known or suspected drug or alcohol abuse
Uncontrolled psychiatric disease that could interfere with study participation
Fibromyalgia
Primary purpose
Allocation
Interventional model
Masking
213 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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