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

Duhon BS, Cher DJ, Wine KD, Kovalsky DA, Lockstadt H, SIFI Study Gro - Global Spine J (2015)

Bottom Line: Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each).SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001).At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again.

View Article: PubMed Central - PubMed

Affiliation: Neurosurgical and Spine Specialists, Parker, Colorado, United States.

ABSTRACT
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. Patient satisfaction with surgery was assessed at 6 and 12 months. Results Mean SI joint pain improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively (mean improvements of 49.9 and 49.1 points, p < 0.0001 each). Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each). SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001). At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again. Conclusions Minimally invasive SI joint fusion resulted in improvement of pain, disability, and quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption.

No MeSH data available.


Related in: MedlinePlus

(A) Intraoperative fluoroscopic images showing postplacement outlet (left), inlet (right), and lateral (lower) views. (B) iFuse implant (SI-BONE, Inc., San Jose, California, United States).
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FI1500059-1: (A) Intraoperative fluoroscopic images showing postplacement outlet (left), inlet (right), and lateral (lower) views. (B) iFuse implant (SI-BONE, Inc., San Jose, California, United States).

Mentions: Subjects underwent index-side minimally invasive SI joint fusion as described previously within 30 days of baseline assessment.36 Under general anesthesia, the subject was placed in the prone position on a radiolucent table. A 3- to 5-cm lateral buttocks incision was made, and dissection was carried down to the gluteal fascia to reach the outer table of the ilium. A guide pin was inserted through the ilium across the SI joint into the body of the sacrum, avoiding the sacral neural foramen. Pin placement was confirmed with lateral, inlet, and outlet fluoroscopic views of the pelvis. A soft tissue protector was passed over the pin, followed by use of a drill to create a pathway through the ilium and into the sacrum, and to decorticate the articular surfaces of the joint. A triangular broach was then used to further decorticate the joint and prepare the pathway for placement of the implant (Fig. 1), which was driven into place. Using a parallel drill guide, additional implants (usually a total of three) were placed across the SI joint. Typically, the most cephalad implant was placed within the sacral ala above the S1 foramen, the second implant was positioned above or adjacent to the S1 foramen, and the third implant was positioned between the S1 and S2 foramen. The incision was irrigated and the tissue layers closed in a standard fashion. Subjects requiring treatment of both SI joints could undergo either bilateral same-day surgery or staged surgery.


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

Duhon BS, Cher DJ, Wine KD, Kovalsky DA, Lockstadt H, SIFI Study Gro - Global Spine J (2015)

(A) Intraoperative fluoroscopic images showing postplacement outlet (left), inlet (right), and lateral (lower) views. (B) iFuse implant (SI-BONE, Inc., San Jose, California, United States).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4836932&req=5

FI1500059-1: (A) Intraoperative fluoroscopic images showing postplacement outlet (left), inlet (right), and lateral (lower) views. (B) iFuse implant (SI-BONE, Inc., San Jose, California, United States).
Mentions: Subjects underwent index-side minimally invasive SI joint fusion as described previously within 30 days of baseline assessment.36 Under general anesthesia, the subject was placed in the prone position on a radiolucent table. A 3- to 5-cm lateral buttocks incision was made, and dissection was carried down to the gluteal fascia to reach the outer table of the ilium. A guide pin was inserted through the ilium across the SI joint into the body of the sacrum, avoiding the sacral neural foramen. Pin placement was confirmed with lateral, inlet, and outlet fluoroscopic views of the pelvis. A soft tissue protector was passed over the pin, followed by use of a drill to create a pathway through the ilium and into the sacrum, and to decorticate the articular surfaces of the joint. A triangular broach was then used to further decorticate the joint and prepare the pathway for placement of the implant (Fig. 1), which was driven into place. Using a parallel drill guide, additional implants (usually a total of three) were placed across the SI joint. Typically, the most cephalad implant was placed within the sacral ala above the S1 foramen, the second implant was positioned above or adjacent to the S1 foramen, and the third implant was positioned between the S1 and S2 foramen. The incision was irrigated and the tissue layers closed in a standard fashion. Subjects requiring treatment of both SI joints could undergo either bilateral same-day surgery or staged surgery.

Bottom Line: Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each).SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001).At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again.

View Article: PubMed Central - PubMed

Affiliation: Neurosurgical and Spine Specialists, Parker, Colorado, United States.

ABSTRACT
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. Patient satisfaction with surgery was assessed at 6 and 12 months. Results Mean SI joint pain improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively (mean improvements of 49.9 and 49.1 points, p < 0.0001 each). Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each). SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001). At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again. Conclusions Minimally invasive SI joint fusion resulted in improvement of pain, disability, and quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption.

No MeSH data available.


Related in: MedlinePlus