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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

Improvement in VAS SI joint pain (A) and Oswestry Disability Index (B). Abbreviations: SE, standard error; SIJ, sacroiliac joint; VAS, visual analog scale.
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FI1500059-4: Improvement in VAS SI joint pain (A) and Oswestry Disability Index (B). Abbreviations: SE, standard error; SIJ, sacroiliac joint; VAS, visual analog scale.

Mentions: During follow-up, mean (SD) SI joint pain improved from a baseline of 79.8 points to 30.0 points at 6 months and 30.4 at 12 months (Table 4 and Fig. 4). Changes from baseline in VAS SI joint pain (49 to 50 points at each time point 3 months or thereafter) were statistically significant (p < 0.0001) and clinically substantial. At 3, 6, and 12 months, the proportion with pain improvements of ≥20 points was 88, 82, and 82%, respectively. The proportion with improvements of ≥40 points at 3, 6, and 12 months was 64, 68, and 66%, respectively. ODI score, a measurement of disability due to back pain, improved from a mean baseline score of 55.2 to 32.5 at 6 months and 31.4 at 12 months. Improvements from baseline in ODI at 3, 6, and 12 months (−21.3, −22.7, and −23.9 points, respectively) were statistically significant and clinically substantial. At 6 and 12 months, 129 (76%) and 122 (77%) subjects had an ODI improvement of 10 or more points and 111 (66%) and 106 (67.0%) had an improvement of 15 or more points. No important difference in pain improvement or ODI were observed across prespecified subgroups except that current smokers had a somewhat diminished ODI response compared with nonsmokers (∼6 points less, p = 0.0710).


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)

Improvement in VAS SI joint pain (A) and Oswestry Disability Index (B). Abbreviations: SE, standard error; SIJ, sacroiliac joint; VAS, visual analog scale.
© Copyright Policy
Related In: Results  -  Collection

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

FI1500059-4: Improvement in VAS SI joint pain (A) and Oswestry Disability Index (B). Abbreviations: SE, standard error; SIJ, sacroiliac joint; VAS, visual analog scale.
Mentions: During follow-up, mean (SD) SI joint pain improved from a baseline of 79.8 points to 30.0 points at 6 months and 30.4 at 12 months (Table 4 and Fig. 4). Changes from baseline in VAS SI joint pain (49 to 50 points at each time point 3 months or thereafter) were statistically significant (p < 0.0001) and clinically substantial. At 3, 6, and 12 months, the proportion with pain improvements of ≥20 points was 88, 82, and 82%, respectively. The proportion with improvements of ≥40 points at 3, 6, and 12 months was 64, 68, and 66%, respectively. ODI score, a measurement of disability due to back pain, improved from a mean baseline score of 55.2 to 32.5 at 6 months and 31.4 at 12 months. Improvements from baseline in ODI at 3, 6, and 12 months (−21.3, −22.7, and −23.9 points, respectively) were statistically significant and clinically substantial. At 6 and 12 months, 129 (76%) and 122 (77%) subjects had an ODI improvement of 10 or more points and 111 (66%) and 106 (67.0%) had an improvement of 15 or more points. No important difference in pain improvement or ODI were observed across prespecified subgroups except that current smokers had a somewhat diminished ODI response compared with nonsmokers (∼6 points less, p = 0.0710).

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