Duhon B.S.,Aurora University |
Bitan F.,Manhattan Orthopedic Spine |
Lockstadt H.,Care at Hand |
Cher D.,Si Bone Inc. |
And 62 more authors.
International Journal of Spine Surgery | Year: 2015
Background Sacroiliac joint (SIJ) dysfunction is an underdiagnosed condition. Several published cohorts have reported favorable mid-term outcomes after SIJ fusion using titanium implants placed across the SIJ. Herein we report long-term (24-month) results from a prospective multicenter clinical trial. Methods One hundred and seventy-two subjects at 26 US sites with SI joint dysfunction were enrolled and underwent minimally invasive SI joint fusion with triangular titanium implants. Subjects underwent structured assessments preoperatively and at 1, 3, 6, 12, 18 and 24 months postoperatively, including SIJ pain ratings (0-100 visual analog scale), Oswestry Disability Index (ODI), Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and patient satisfaction. Adverse events were collected throughout follow-up. All participating patients underwent a high-resolution pelvic CT scan at 1 year. Results Mean subject age was 50.9 years and 69.8% were women. SIJ pain was present for an average of 5.1 years prior to surgical treatment. SIJ pain decreased from 79.8 at baseline to 30.4 at 12 months and remained low at 26.0 at 24 months (p<.0001 for change from baseline). ODI decreased from 55.2 at baseline to 31.5 at 12 months and remained low at 30.9 at 24 months (p<.0001 for change from baseline). Quality of life (SF-36 and EQ-5D) improvements seen at 12 months were sustained at 24 months. The proportion of subjects taking opioids for SIJ or low back pain decreased from 76.2% at baseline to 55.0% at 24 months (p <.0001). To date, 8 subjects (4.7%) have undergone one or more revision SIJ surgeries. 7 device-related adverse events occurred. CT scan at one year showed a high rate (97%) of bone adherence to at least 2 implants on both the iliac and sacral sides with modest rates of bone growth across the SIJ. Conclusions In this study of patients with SIJ dysfunction, minimally invasive SI joint fusion using triangular titanium implants showed marked improvements in pain, disability and quality of life at 2 years. Imaging showed that bone apposition to implants was common but radiographic evidence of intraarticular fusion within the joint may take more than 1 year in many patients. © 2016 ISASS.
Cher D.J.,Si Bone Inc. |
Wine K.D.,Si Bone Inc. |
Lockstadt H.,Care at Hand |
Soo C.-L.,Health Research Institute |
And 39 more authors.
Medical Devices: Evidence and Research | Year: 2013
Background: Sacroiliac (SI) joint pain is an often overlooked cause of low back pain. SI joint arthrodesis has been reported to relieve pain and improve quality of life in patients suffering from degeneration or disruption of the SI joint who have failed non-surgical care. We report herein early results of a multicenter prospective single-arm cohort of patients with SI joint degeneration or disruption who underwent minimally invasive fusion using the iFuse Implant System®. Methods: The safety cohort includes 94 subjects at 23 sites with chronic SI joint pain who met study eligibility criteria and underwent minimally invasive SI joint fusion with the iFuse Implant System® between August 2012 and September 2013. Subjects underwent structured assessments preoperatively, immediately postoperatively, and at 1, 3, and 6 months postoperatively, including SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQoL-5D (EQ-5D). Patient satisfaction with surgery was assessed at 6 months. The effectiveness cohort includes the 32 subjects who have had 6-month follow-up to date. Results: Mean subject age was 51 years (n=94, safety cohort) and 66% of patients were women. Subjects were highly debilitated at baseline (mean VAS pain score 78, mean ODI score 54). Three implants were used in 80% of patients; two patients underwent staged bilateral implants. Twenty-three adverse events occurred within 1 month of surgery and 29 additional events occurred between 30 days and latest follow-up. Six adverse events were severe but none were device-related. Complete 6-month postoperative follow-up was available in 26 subjects. In the effectiveness cohort, mean (± standard deviation) SI joint pain improved from a baseline score of 76 (±16.2) to a 6-month score of 29.3 (±23.3, an improvement of 49 points, P<0.0001), mean ODI improved from 55.3 (±10.7) to 38.9 (±18.5, an improvement of 15.8 points, P<0.0001) and SF-36 PCS improved from 30.7 (±4.3) to 37.0 (±10.7, an improvement of 6.7 points, P=0.003). Ninety percent of subjects who were ambulatory at baseline regained full ambulation by month 6; median time to full ambulation was 30 days. Satisfaction with the procedure was high at 85%. Conclusion: Minimally invasive SI joint fusion using the iFuse Implant System® is safe. Mid-term follow-up indicates a high rate of improvement in pain and function with high rates of patient satisfaction. © 2013 Duhon et al.