Catamaran SI Joint Fusion System(R) MAINSAILTM Study: a prospective, single-arm, multi-center, post-market study of six-month clinical outcomes and twelve-month radiographic findings

Abstract

ABSTRACT Background Minimally invasive surgical techniques for sacroiliac joint (SIJ) fixation have the potential to reduce risk and improve patient outcomes, but evidence remains limited. This interim analysis presents initial findings from an ongoing prospective study evaluating the safety and efficacy of the Catamaran System. Methods The primary endpoint of success at 6 months was defined as a ≥20 mm improvement in SIJ pain (Visual Analog Scale, VAS), no neurologic worsening, absence of device-related serious adverse events (SAEs), and no surgical reintervention. Secondary endpoints included 6 month evaluation of the Oswestry Disability Index (ODI), patient satisfaction, and 12 month radiographic CT fusion, performed by an indpendent radiologist. Results Thirty-three consecutive patients (mean age: 58.9 years; %-females: 76%; Body Mass Index: 30.5) were treated across six U.S. clinical sites. At the primary endpoint of 6 months, 80% of patients met the criteria for success, with no device-related SAEs and no surgical reintervention reported. VASSIJ-Pain significantly decreased from preoperative levels (mean: 80.9 mm) to 6 months postoperatively (31.1 mm; p < 0.001). Mean ODI scores also showed a significant improvement from preoperative values (51.9%) to 6 months postoperatively (29.6%, p < 0.01). Patients reported high satisfaction rates throughout all follow-ups, with 93.3% of patients being satisfied at 6 months. Conclusion In patients diagnosed with chronic SIJ pain, minimally invasive inferior-posterior delivery of the Catamaran implant was safe and effective in relieving pain and reducing disability.