Jacqueline Weisbein, Denis Patterson, Douglas Beall, Dan Nguyen, Jack Smith, Caroline Harstroem, Timothy Davis, Jeffrey Foster, Anne Christopher, Daniel Kloster, John Broadnax, Eric Anderson, John Hatheway, Andrew Trobridge, Charles Simmons, Thomas Stauss, Michael Harned, Christopher Mallard
{"title":"经髂外侧入路微创骶髂关节融合金属植入物的安全性和初步有效性:一项前瞻性试验。","authors":"Jacqueline Weisbein, Denis Patterson, Douglas Beall, Dan Nguyen, Jack Smith, Caroline Harstroem, Timothy Davis, Jeffrey Foster, Anne Christopher, Daniel Kloster, John Broadnax, Eric Anderson, John Hatheway, Andrew Trobridge, Charles Simmons, Thomas Stauss, Michael Harned, Christopher Mallard","doi":"10.1093/pm/pnaf082","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Sacroiliac joint (SIJ) pain, a frequent contributor to low back pain, is commonly treated with minimally invasive SIJ fusion. A large body of evidence supports the safety and effectiveness of lateral transiliac SIJ fusion. Traditionally performed by surgeons, this procedure is increasing in utilization by non-surgeon interventionalists. Herein, we present early safety results from a single-arm clinical trial of participants who underwent lateral SIJ fusion using threaded titanium implants placed by interventional pain management physicians.</p><p><strong>Methods: </strong>STACI (NCT05870488) is a two-year prospective study conducted at 15 US interventional pain management sites. The primary endpoint is change in SIJ pain from baseline to 6-months. Secondary endpoints include changes in function (Oswestry Disability Index), quality of life (PROMIS-29), device or procedure-related adverse events, and evidence of fusion on CT scan at 2 years.</p><p><strong>Results: </strong>110 patients were enrolled. Mean (SD) participant age is 64 (14) years and 68% are female. Mean (SD) operative time was 44 minutes (16) and estimated blood loss was 14 cc (15). No serious or device-related adverse events have occurred. Reported perioperative adverse events include one surgical site infection and one hematoma. At 1-month follow-up, ODI improved by 18 points (p < 0.0001) and SIJ pain (NRS) decreased by 4 pts (p < 0.0001) from baseline.</p><p><strong>Conclusion: </strong>Early results from this prospective multicenter study support the relative safety and early effectiveness of LTI SIJ fusion using a threaded implant when performed by interventional pain management physicians. The data are consistent with published literature with a low adverse event rate and early improvements in pain and function.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial.\",\"authors\":\"Jacqueline Weisbein, Denis Patterson, Douglas Beall, Dan Nguyen, Jack Smith, Caroline Harstroem, Timothy Davis, Jeffrey Foster, Anne Christopher, Daniel Kloster, John Broadnax, Eric Anderson, John Hatheway, Andrew Trobridge, Charles Simmons, Thomas Stauss, Michael Harned, Christopher Mallard\",\"doi\":\"10.1093/pm/pnaf082\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Sacroiliac joint (SIJ) pain, a frequent contributor to low back pain, is commonly treated with minimally invasive SIJ fusion. A large body of evidence supports the safety and effectiveness of lateral transiliac SIJ fusion. Traditionally performed by surgeons, this procedure is increasing in utilization by non-surgeon interventionalists. Herein, we present early safety results from a single-arm clinical trial of participants who underwent lateral SIJ fusion using threaded titanium implants placed by interventional pain management physicians.</p><p><strong>Methods: </strong>STACI (NCT05870488) is a two-year prospective study conducted at 15 US interventional pain management sites. The primary endpoint is change in SIJ pain from baseline to 6-months. Secondary endpoints include changes in function (Oswestry Disability Index), quality of life (PROMIS-29), device or procedure-related adverse events, and evidence of fusion on CT scan at 2 years.</p><p><strong>Results: </strong>110 patients were enrolled. Mean (SD) participant age is 64 (14) years and 68% are female. Mean (SD) operative time was 44 minutes (16) and estimated blood loss was 14 cc (15). No serious or device-related adverse events have occurred. Reported perioperative adverse events include one surgical site infection and one hematoma. At 1-month follow-up, ODI improved by 18 points (p < 0.0001) and SIJ pain (NRS) decreased by 4 pts (p < 0.0001) from baseline.</p><p><strong>Conclusion: </strong>Early results from this prospective multicenter study support the relative safety and early effectiveness of LTI SIJ fusion using a threaded implant when performed by interventional pain management physicians. The data are consistent with published literature with a low adverse event rate and early improvements in pain and function.</p>\",\"PeriodicalId\":19744,\"journal\":{\"name\":\"Pain Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-06-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/pm/pnaf082\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/pm/pnaf082","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial.
Purpose: Sacroiliac joint (SIJ) pain, a frequent contributor to low back pain, is commonly treated with minimally invasive SIJ fusion. A large body of evidence supports the safety and effectiveness of lateral transiliac SIJ fusion. Traditionally performed by surgeons, this procedure is increasing in utilization by non-surgeon interventionalists. Herein, we present early safety results from a single-arm clinical trial of participants who underwent lateral SIJ fusion using threaded titanium implants placed by interventional pain management physicians.
Methods: STACI (NCT05870488) is a two-year prospective study conducted at 15 US interventional pain management sites. The primary endpoint is change in SIJ pain from baseline to 6-months. Secondary endpoints include changes in function (Oswestry Disability Index), quality of life (PROMIS-29), device or procedure-related adverse events, and evidence of fusion on CT scan at 2 years.
Results: 110 patients were enrolled. Mean (SD) participant age is 64 (14) years and 68% are female. Mean (SD) operative time was 44 minutes (16) and estimated blood loss was 14 cc (15). No serious or device-related adverse events have occurred. Reported perioperative adverse events include one surgical site infection and one hematoma. At 1-month follow-up, ODI improved by 18 points (p < 0.0001) and SIJ pain (NRS) decreased by 4 pts (p < 0.0001) from baseline.
Conclusion: Early results from this prospective multicenter study support the relative safety and early effectiveness of LTI SIJ fusion using a threaded implant when performed by interventional pain management physicians. The data are consistent with published literature with a low adverse event rate and early improvements in pain and function.
期刊介绍:
Pain Medicine is a multi-disciplinary journal dedicated to pain clinicians, educators and researchers with an interest in pain from various medical specialties such as pain medicine, anaesthesiology, family practice, internal medicine, neurology, neurological surgery, orthopaedic spine surgery, psychiatry, and rehabilitation medicine as well as related health disciplines such as psychology, neuroscience, nursing, nurse practitioner, physical therapy, and integrative health.