Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 5-Year Follow-Up.

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.

Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up.

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.

Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants.

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.

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.

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

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. To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction. 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).

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

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 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).

Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial.

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.

Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study.

Study Design Prospective multicenter single-arm interventional clinical trial. Objective To determine the degree of improvement in sacroiliac (SI) joint pain, disability related to SI joint pain, and quality of life in patients with SI joint dysfunction who undergo minimally invasive SI joint fusion using triangular-shaped titanium implants. Methods Subjects (n = 172) underwent minimally invasive SI joint fusion between August 2012 and January 2014 and completed structured assessments preoperatively and at 1, 3, 6, and 12 months postoperatively, including a 100-mm SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQOL-5D.

Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes.

Background: Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain.

Objective: To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction.

Methods: A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46).

Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial.

Background: Sacroiliac (SI) joint pain is a prevalent, underdiagnosed cause of lower back pain. SI joint fusion can relieve pain and improve quality of life in patients who have failed nonoperative care. To date, no study has concurrently compared surgical and non-surgical treatments for chronic SI joint dysfunction.

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).

Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study.

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®.