Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System.
• Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
‣ Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and
⁃ Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain (Fabers, Compression, Distraction,Thigh thrust, Gaenslen's test, and/or Sacral thrust test), and
⁃ Patient has improvement in lower back pain VAS of at least 50% of the pre injection VAS after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test \<6 months ago)
• Patient has failed conservative care (non-surgical) \> 6 months
• Patient has a pre-operative Oswestry Disability Index score \> 30%
• Patient has a pre-operative SI joint pain score of \> 50 on a 0-100 mm visual analog scale (VAS)
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study
• Patient is willing and able to complete study follow-up requirements