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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

Patient flow. Some subjects who missed the 1- or 3-month visit returned for subsequent visits (dashed lines).
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FI1500059-3: Patient flow. Some subjects who missed the 1- or 3-month visit returned for subsequent visits (dashed lines).

Mentions: Trial follow-up was excellent. Of the 172 participants, 169 (98%) had 6-month follow-up and 157 (91%) had 12-month follow-up (Fig. 3). Reasons for study exit prior to the 12-month visit included withdrawal of consent (n = 2) and loss to follow-up (n = 7). Six subjects missed the 12-month study visit but had not exited the study.


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)

Patient flow. Some subjects who missed the 1- or 3-month visit returned for subsequent visits (dashed lines).
© Copyright Policy
Related In: Results  -  Collection

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

FI1500059-3: Patient flow. Some subjects who missed the 1- or 3-month visit returned for subsequent visits (dashed lines).
Mentions: Trial follow-up was excellent. Of the 172 participants, 169 (98%) had 6-month follow-up and 157 (91%) had 12-month follow-up (Fig. 3). Reasons for study exit prior to the 12-month visit included withdrawal of consent (n = 2) and loss to follow-up (n = 7). Six subjects missed the 12-month study visit but had not exited the study.

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