RESUMEN
STUDY DESIGN: Prospective, multicenter, single arm study with 5-year follow up. OBJECTIVE: To report long-term (5-year) safety, effectiveness, and radiographic outcomes after sacroiliac (SI) joint fusion (SIJF) with 3D-printed triangular titanium implants (TTI) and compare them with solid titanium plasma spray coated implants. SUMMARY OF BACKGROUND DATA: A large literature base supports minimally invasive SIJF with TTI for chronic SIJ dysfunction. METHODS: SIJF with TTI was performed in 51 subjects and scheduled follow-up occurred at 3, 6, 12, 24 and 60 months. Postoperative visits included quality of life questionnaires and functional tests. A high-resolution CT scan was performed at either 6 or 12 months, and again at 60 months. All CT scans were interpreted by an independent musculoskeletal radiologist. RESULTS: 5-year follow-up was available in 36 of 51 subjects (71%). At 5 years, improvements in SI joint pain (58.1 points [0-100 scale]), SIJ-related disability (Oswestry Disability Index [ODI], 25.4 points) and quality of life (EuroQOL 5D, 0.24 points, and EuroQOL visual analog scale, 13.4 points) were sustained and showed no signs of diminution. The percentage of patients using opioids for SIJ pain decreased markedly from baseline (57%) to 5 years (17%). Physical function tests showed persistent improvements from baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. Independent analysis of CT scans showed bone opposed to implants in all cases, and evidence of bone bridging in 90% of cases, and no evidence of radiolucency or other adverse bone reactions. CONCLUSIONS: Prospective 5-year follow-up showed that SIJ fusion using 3D-printed TTI resulted in immediate, marked, and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use, and a low rate of revision surgery. Radiographic evidence showed implant integration and joint fusion. LEVEL OF EVIDENCE: Level II.
RESUMEN
BACKGROUND: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months. METHODS: SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits. RESULTS: 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0-100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. CONCLUSION: In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events. LEVEL OF EVIDENCE: Level II.
RESUMEN
BACKGROUND: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To assess the safety and effectiveness of SIJF using a 3D-printed TTI. METHODS: Fifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints. RESULTS: Ninety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p<.0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P<.0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence. CONCLUSION: In this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed. LEVEL OF EVIDENCE: Level II.