The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.
This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.
Study Type
OBSERVATIONAL
Enrollment
17
SImmetry The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.
Reno Orthaepedic Clinic
Reno, Nevada, United States
SI Joint Fusion
Number of participants with radiographic evidence of fusion of the SI joint, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.
Time frame: 24 months
SI Joint Pain Reduction
SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.
Time frame: 6 months
SI Joint Pain Reduction
SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.
Time frame: 24 Months
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