Minimally invasive lateral transiliac sacroiliac joint fusion using 3D-printed triangular titanium implants

Vikas Patel,1 Don Kovalsky,2 S Craig Meyer,3 Abhineet Chowdhary,4 Harry Lockstadt,5 Fernando Techy,6 James Billys,7 Robert Limoni,8 Philip S Yuan,9 Andy Kranenburg,10 Daniel Cher,11 Gabriel Tender121Department of Orthopedics, University of Colorado, Aurora, CO, USA; 2Orthopaedic Center of Southern Illinois, Mt. Vernon, IL, USA; 3Columbia Orthopaedic Medical Group, Columbia, MO, USA; 4Overlake Medical Center, Bellevue, WA, USA; 5Bluegrass Orthopaedics, Lexington, KY, USA; 6ClinTech Center for Spine Health, Johnstown, CO, USA; 7The B.A.C.K. Center, Melbourne, FL, USA; 8BayCare Clinic Orthopedics & Sports Medicine, Green Bay, WI, USA; 9Memorial Orthopaedic Surgical Group, Long Beach, CA, USA; 10South Oregon Orthopedics, Medford, OR, USA; 11SI-BONE, Inc., Santa Clara, CA, USA; 12Department of Neurosurgery, Louisiana State University, New Orleans, LA, USABackground: Minimally invasive sacroiliac joint (SIJ) fusion (SIJF) has become an increasingly accepted surgical option for chronic SI joint dysfunction, a prevalent cause of chronic low back/buttock pain.Objective: To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction.Methods: A total of 28 subjects with SIJ dysfunction at 8 centers underwent SIJF with 3D TTI and had scheduled follow-up to 6 months (NCT03122899).Results: Mean preoperative SIJ pain score was 79.1 and mean preoperative Oswestry Disability Index (ODI) was 49.9. At 6 months, pain scores decreased by 51 points and ODI decreased by 23.6 points (both p<0.0001). The proportion of subjects able to perform various back/pelvis-related physical functions with minimal difficulty improved significantly for nearly all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved.Conclusion: Early results from this prospective multicenter trial confirm that clinical responses to a 3D triangular titanium implant for SIJF are similar to those from prior trials, with improved physical function and decreased opioid use.Level of evidence: Level II.Keywords: spine surgery, pelvic pain, osteoarthritis, arthrodesi

Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials

Background: Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. Materials and methods: Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). Results: Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29. Conclusions: Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant. (C) 2015 Elsevier Inc. All rights reserved

Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants

Emily Darr,1 S Craig Meyer,2 Peter G Whang,3 Don Kovalsky,4 Clay Frank,5 Harry Lockstadt,6 Robert Limoni,7 Andy Redmond,8 Philip Ploska,9 Michael Y Oh,10 Daniel Cher,11 Abhineet Chowdhary12 1Orthopaedics and Physical Medicine, Medical University of South Carolina, Charleston, SC, USA; 2Columbia Orthopaedic Medical Group, Columbia, MO, USA; 3Department of Orthopedics, Yale University, New Haven, CT, USA; 4Orthopaedic Center of Southern Illinois, Mt. Vernon, IL, USA; 5Integrated Spine Care, Wauwatosa, WI, USA; 6Bluegrass Orthopedics, Lexington, KY, USA; 7Orthopedics &amp; Sports Medicine, BayCare Clinic, Green Bay, WI, USA; 8Precision Spine Care, Tyler, TX, USA; 9OrthoSpine Solutions, Stockbridge, GA, USA; 10Allegheny General Hospital, Pittsburgh, PA, USA; 11SI-BONE, Inc., San Jose, CA, USA; 12Overlake Medical Center, Bellevue, WA, USA Background: Minimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain. Objective: The objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3&nbsp;years postoperatively. Methods: A total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5&nbsp;years. Results: Mean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3&nbsp;years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p&lt;0.0001). At 3&nbsp;years, mean ODI was 28.2 (a 28-point improvement from baseline, p&lt;0.0001). In all, 82% of subjects were very satisfied with the procedure at 3&nbsp;years. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p&lt;0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3&nbsp;years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3&nbsp;years compared to earlier time points. Conclusion: In long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates. Level of evidence: Level II. Clinical relevance: SIJF with TTI. Keywords: sacroiliac joint fusion, chronic low back pain, multicenter stud

Suivi traumatologique d'une équipe de la ligue nationale de rugby, saison 1998-1999

Background: Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. Materials and methods: Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). Results: Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P <0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P <0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29. Conclusions: Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant. (C) 2015 Elsevier Inc. All rights reserved