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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 SF-36 domains at 6 months compared with baseline. All p < 0.0001 versus baseline except for GH (p = 0.0063 for 6 months versus baseline and p = 0.0031 for 12 months versus baseline). Solid line = baseline; dotted line = month 6; dashed line = month 12. Abbreviations: SF-36, Short Form-36; SE, standard error; BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RE, role emotional; RP, role physical; SF, social function; VT, vitality.
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FI1500059-5: Improvement in SF-36 domains at 6 months compared with baseline. All p < 0.0001 versus baseline except for GH (p = 0.0063 for 6 months versus baseline and p = 0.0031 for 12 months versus baseline). Solid line = baseline; dotted line = month 6; dashed line = month 12. Abbreviations: SF-36, Short Form-36; SE, standard error; BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RE, role emotional; RP, role physical; SF, social function; VT, vitality.

Mentions: Quality of life was measured using two generic assessments, EQ-5D and SF-36. Mean EQ-5D time trade-off index improved from 0.43 at baseline to 0.69 at 6 months and 0.71 at 12 months, increases of 0.25 and 0.27 points, respectively (Table 4, p < 0.0001). Mean EQ-5D global health thermometer rating improved from 57.1 at baseline to 69.1 at 6 months and 68.8 at 12 months (improvements of 12.1 and 11.4 points, p < 0.0001). All SF-36 individual domains showed statistically significant improvements (p = 0.006 and 0.003 for general health at 6 and 12 months, respectively, and p < 0.0001 for all other domains and time points, Fig. 5). SF-36 PCS and MCS were depressed at baseline (mean 31.7 and 38.5, respectively); by 6 and 12 months after SI joint fusion, respectively, these values improved by 8.4 and 8.7 points for PCS and 9.4 and 9.2 points for MCS (p < 0.0001 each). Satisfaction rates were high: at 6 and 12 months, most (93.5 and 87.3%) were somewhat or very satisfied. Similarly, 92.3 and 91.1% of subjects stated at 6 and 12 months that they might or would definitely have the procedure again. Opioid use decreased somewhat from 76% at baseline to 60% at 6-month follow-up and 57% at 12 months.


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 SF-36 domains at 6 months compared with baseline. All p < 0.0001 versus baseline except for GH (p = 0.0063 for 6 months versus baseline and p = 0.0031 for 12 months versus baseline). Solid line = baseline; dotted line = month 6; dashed line = month 12. Abbreviations: SF-36, Short Form-36; SE, standard error; BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RE, role emotional; RP, role physical; SF, social function; VT, vitality.
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4836932&req=5

FI1500059-5: Improvement in SF-36 domains at 6 months compared with baseline. All p < 0.0001 versus baseline except for GH (p = 0.0063 for 6 months versus baseline and p = 0.0031 for 12 months versus baseline). Solid line = baseline; dotted line = month 6; dashed line = month 12. Abbreviations: SF-36, Short Form-36; SE, standard error; BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RE, role emotional; RP, role physical; SF, social function; VT, vitality.
Mentions: Quality of life was measured using two generic assessments, EQ-5D and SF-36. Mean EQ-5D time trade-off index improved from 0.43 at baseline to 0.69 at 6 months and 0.71 at 12 months, increases of 0.25 and 0.27 points, respectively (Table 4, p < 0.0001). Mean EQ-5D global health thermometer rating improved from 57.1 at baseline to 69.1 at 6 months and 68.8 at 12 months (improvements of 12.1 and 11.4 points, p < 0.0001). All SF-36 individual domains showed statistically significant improvements (p = 0.006 and 0.003 for general health at 6 and 12 months, respectively, and p < 0.0001 for all other domains and time points, Fig. 5). SF-36 PCS and MCS were depressed at baseline (mean 31.7 and 38.5, respectively); by 6 and 12 months after SI joint fusion, respectively, these values improved by 8.4 and 8.7 points for PCS and 9.4 and 9.2 points for MCS (p < 0.0001 each). Satisfaction rates were high: at 6 and 12 months, most (93.5 and 87.3%) were somewhat or very satisfied. Similarly, 92.3 and 91.1% of subjects stated at 6 and 12 months that they might or would definitely have the procedure again. Opioid use decreased somewhat from 76% at baseline to 60% at 6-month follow-up and 57% at 12 months.

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