Catamaran SI Joint Fusion System (R) MAINSAIL TM Study: a prospective, single-arm, multi-center, post-market study of six-month clinical outcomes and twelve-month radiographic findings
Year: 2024
Type: article
Study design: Clinical Trial
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 SI joint pain (VASSIJ-Pain), no neurologic worsening, absence of device-related serious adverse events (SAEs), and no surgical re-intervention. Secondary endpoints included evaluation of the Oswestry Disability Index (ODI) and patient satisfaction.Results 33 consecutive patients (Age: 58.9 yrs. %-females: 76%; BMI: 30.5) were treated across six US 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 re-intervention reported. VASSIJPain 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 with diagnosed chronic SIJ pain, minimally invasive inferior-posterior delivery of an SIJ device was safe and effective in relieving pain and reducing disability.
Source: Expert Review of Medical Devices
Authors: Matthew Davies, Marcel Dreischarf, Rachelle Yusufbekov
Institution: Johns Hopkins University
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4401715115