Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants

Background: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. Objective: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI). Methods: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist. Results: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0 – 1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%). Conclusion: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. Level of evidence: Level II.

[1]  D. Cher,et al.  Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint , 2019, The Journal of bone and joint surgery. American volume.

[2]  S. Yerby,et al.  Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion , 2018, Medical devices.

[3]  D. Cher,et al.  Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating From the Sacroiliac Joint , 2017, Spine.

[4]  A. Gasbarrini,et al.  Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management , 2017, European Spine Journal.

[5]  D. Cher,et al.  Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction , 2016, International Journal of Spine Surgery.

[6]  Harlan M Krumholz,et al.  The Yale Open Data Access (YODA) Project--A Mechanism for Data Sharing. , 2016, The New England journal of medicine.

[7]  D. Cher,et al.  Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial , 2016, International Journal of Spine Surgery.

[8]  D. Cher,et al.  Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System® , 2015, Medical devices.

[9]  S. Yerby,et al.  Sacroiliac Joint Fusion Minimally Affects Adjacent Lumbar Segment Motion: A Finite Element Study , 2015, International Journal of Spine Surgery.

[10]  D. Cher,et al.  Quality of life in preoperative patients with sacroiliac joint dysfunction is at least as depressed as in other lumbar spinal conditions , 2015, Medical devices.

[11]  R. Capobianco,et al.  Five-Year Clinical and Radiographic Outcomes After Minimally Invasive Sacroiliac Joint Fusion Using Triangular Implants , 2014, The open orthopaedics journal.

[12]  M. Swiontkowski,et al.  Comparative effectiveness of open versus minimally invasive sacroiliac joint fusion , 2014, Medical devices.

[13]  D. Cher,et al.  Sacroiliac joint pain: burden of disease , 2014, Medical devices.

[14]  M. Swiontkowski,et al.  Minimally Invasive Versus Open Sacroiliac Joint Fusion: Are They Similarly Safe and Effective? , 2014, Clinical orthopaedics and related research.

[15]  O. Boachie-Adjei,et al.  Early Results of Sacro–Iliac Joint Fixation Following Long Fusion to the Sacrum in Adult Spine Deformity , 2014, HSS Journal ®.

[16]  D. Cher,et al.  Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes , 2013, Annals of surgical innovation and research.

[17]  R. Capobianco,et al.  Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients , 2013, Annals of surgical innovation and research.

[18]  R. Capobianco,et al.  Minimally Invasive Sacroiliac Joint Fusion: One-Year Outcomes in 40 Patients , 2013, Advances in orthopedics.

[19]  L. Miller,et al.  Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption , 2013, Medical devices.

[20]  R. Capobianco,et al.  One year successful outcomes for novel sacroiliac joint arthrodesis system , 2012, Annals of surgical innovation and research.

[21]  L. Rudolf.  Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes , 2012, The open orthopaedics journal.

[22]  N. Patel,et al.  A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. , 2012, Pain medicine.

[23]  W. Kim,et al.  A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. , 2010, Journal of alternative and complementary medicine.

[24]  D. Polly,et al.  How Often Is Low Back Pain Not Coming From the Back? , 2009, Spine.

[25]  Steven P. Cohen,et al.  Randomized Placebo-controlled Study Evaluating Lateral Branch Radiofrequency Denervation for Sacroiliac Joint Pain , 2008, Anesthesiology.

[26]  W. Ambrosius,et al.  Age, Body Mass Index, and Gender Differences in Sacroiliac Joint Pathology , 2007, American journal of physical medicine & rehabilitation.

[27]  D. Holdsworth,et al.  Computed Tomographic Analysis of Bone Support for Three Acetabular Cup Designs , 2005, Clinical orthopaedics and related research.

[28]  P. Pynsent,et al.  The Oswestry Disability Index. , 2000, Spine.

[29]  F. Falco,et al.  The Fortin finger test: an indicator of sacroiliac pain. , 1997, American journal of orthopedics.

[30]  J. Maigne,et al.  Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients With Low Back Pain , 1996, Spine.

[31]  Y. Maugars,et al.  Assessment of the efficacy of sacroiliac corticosteroid injections in spondylarthropathies: a double-blind study. , 1996, British journal of rheumatology.

[32]  N. Bogduk,et al.  The Sacroiliac Joint in Chronic Low Back Pain , 1995, Spine.

[33]  T N Bernard,et al.  Recognizing specific characteristics of nonspecific low back pain. , 1987, Clinical orthopaedics and related research.

[34]  V. Vanaclocha,et al.  Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation, and Conservative Management for Sacroiliac Joint Pain: 6‐Year Comparative Case Series , 2018, Neurosurgery.

[35]  P. Wennerstrand,et al.  Efficacy of periarticular corticosteroid treatment of the sacroiliac joint in non-spondylarthropathic patients with chronic low back pain in the region of the sacroiliac joint. , 2002, Clinical and experimental rheumatology.

[36]  H. Kautiainen,et al.  Periarticular corticosteroid treatment of the sacroiliac joint in patients with seronegative spondylarthropathy. , 1999, Clinical and experimental rheumatology.

[37]  A. Kasuya.  EuroQol--a new facility for the measurement of health-related quality of life. , 1990, Health policy.

[38]  L. Rudolf.  Send Orders of Reprints at Reprints@benthamscience.net Mis Fusion of the Si Joint: Does Prior Lumbar Spinal Fusion Affect Patient Outcomes? , 2022 .