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

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Abstract

Supplemental Digital Content is Available in the Text.

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). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete.

RESULTS:

Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group ( P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31).

CONCLUSION:

This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.

ABBREVIATIONS:

EQ-5D, EuroQoL-5D

INSITE, Investigation of Sacroiliac Fusion Treatment

MCS, mental component summary

NSM, nonsurgical management

ODI, Oswestry Disability Index

PCS, physical component summary

RFA, radiofrequency ablation

SF-36, Short Form-36

SIJ, sacroiliac joint

TTO, time trade-off

VAS, visual analog scale

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Most cited references 54

Record: found
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Article: not found

Responsiveness of the numeric pain rating scale in patients with low back pain.

John Childs, Sara Piva, Julie M Fritz (2005)

Cohort study of patients with low back pain (LBP) receiving physical therapy. To examine the responsiveness characteristics of the numerical pain rating scale (NPRS) in patients with LBP using a variety of methods. Although several studies have assessed the reliability and validity of the NPRS, few studies have characterized its responsiveness in patients with LBP. Determination of change on the NPRS during 1 and 4 weeks was examined by calculating mean change, standardized effect size, Guyatt Responsiveness Index, area under a receiver operating characteristic curve, minimum clinically important difference, and minimum detectable change. Change in the NPRS from baseline to the 1 and 4-week follow-up was compared to the average of the patient and therapist's perceived improvement using the 15-point Global Rating of Change scale. The majority of patients had clinically meaningful improvement after both 1 and 4 weeks of rehabilitation. The standard error of measure was equal to 1.02, corresponding to a minimum detectable change of 2 points. The area under the curve at the 1 and 4-week follow-up was 0.72 (0.62, 0.81) and 0.92 (0.86, 0.97), respectively. The minimum clinically important difference at the 1 and 4-week follow-up corresponded to a change of 2.2 and 1.5 points, respectively. Clinicians can be confident that a 2-point change on the NPRS represents clinically meaningful change that exceeds the bounds of measurement error.

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Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

Jack S Emery, Harry Herkowitz, John N Weinstein … (2009)

The management of degenerative spondylolisthesis associated with spinal stenosis remains controversial. Surgery is widely used and has recently been shown to be more effective than nonoperative treatment when the results were followed over two years. Questions remain regarding the long-term effects of surgical treatment compared with those of nonoperative treatment. Surgical candidates from thirteen centers with symptoms of at least twelve weeks' duration as well as confirmatory imaging showing degenerative spondylolisthesis with spinal stenosis were offered enrollment in a randomized cohort or observational cohort. Treatment consisted of standard decompressive laminectomy (with or without fusion) or usual nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at six weeks, three months, six months, and yearly up to four years. In the randomized cohort (304 patients enrolled), 66% of those randomized to receive surgery received it by four years whereas 54% of those randomized to receive nonoperative care received surgery by four years. In the observational cohort (303 patients enrolled), 97% of those who chose surgery received it whereas 33% of those who chose nonoperative care eventually received surgery. The intent-to-treat analysis of the randomized cohort, which was limited by nonadherence to the assigned treatment, showed no significant differences in treatment outcomes between the operative and nonoperative groups at three or four years. An as-treated analysis combining the randomized and observational cohorts that adjusted for potential confounders demonstrated that the clinically relevant advantages of surgery that had been previously reported through two years were maintained at four years, with treatment effects of 15.3 (95% confidence interval, 11 to 19.7) for bodily pain, 18.9 (95% confidence interval, 14.8 to 23) for physical function, and -14.3 (95% confidence interval, -17.5 to -11.1) for the Oswestry Disability Index. Early advantages (at two years) of surgical treatment in terms of the secondary measures of bothersomeness of back and leg symptoms, overall satisfaction with current symptoms, and self-rated progress were also maintained at four years. Compared with patients who are treated nonoperatively, patients in whom degenerative spondylolisthesis and associated spinal stenosis are treated surgically maintain substantially greater pain relief and improvement in function for four years.

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Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort.

Jeffrey S Fischgrund, Frank Cammisa, John N Weinstein … (2006)

For patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care. To compare the treatment effects of diskectomy and usual care. Prospective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003. Standard open diskectomy vs usual nonoperative care. Changes from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version). Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery -37.6 vs nonoperative care -24.2; treatment effect, -13.4; 95% CI, -17.0 to -9.7). Patients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously. clinicaltrials.gov Identifier: NCT00000410.

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Author and article information

Journal

Journal ID (nlm-ta): Neurosurgery

Journal ID (iso-abbrev): Neurosurgery

Journal ID (publisher-id): neu

Title: Neurosurgery

Publisher: Neurosurgery

ISSN (Print): 0148-396X

ISSN (Electronic): 1524-4040

Publication date (Electronic): 19 August 2015

Publication date (Print): November 2015

Volume: 77

Issue: 5

Pages: 674-691

Affiliations

[* ]Departments of Orthopedic Surgery and Neurosurgery, University of Minnesota, Minneapolis, Minnesota;

[‡ ]SI-BONE, Inc, San Jose, California;

[§ ]Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, Connecticut;

[¶ ]Integrated Spine Care, Wauwatosa, Wisconsin;

[‖ ]Riverside Hospital, Kankakee, Illinois;

[# ]Bluegrass Orthopedics and Hand Care, Lexington, Kentucky;

[** ]Medical University of South Carolina, Charleston, South Carolina;

[‡‡ ]Aurora BayCare Orthopedic and Sports Medicine Center, Green Bay, Wisconsin;

[§§ ]Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota

Author notes

Correspondence: Daniel J. Cher, MD, 3055 Olin Ave, Ste 2200, San Jose, CA 95128. E-mail: dcher@ 123456si-bone.com

Article

Publisher ID: NEU-D-15-00771 Accession ID: 00002

DOI: 10.1227/NEU.0000000000000988

PMC ID: 4605280

PubMed ID: 26291338

SO-VID: 3b0616ba-474f-4230-87c9-15f1a89cf422

License:

Copyright © 2015 by the Congress of Neurological Surgeons. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.

History

Date received : 25 June 2015

Date accepted : 22 July 2015

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Keywords: sacroiliac joint dysfunction,chronic lower back pain,randomized controlled trial,minimally invasive surgery

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Keywords: sacroiliac joint dysfunction, chronic lower back pain, randomized controlled trial, minimally invasive surgery

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

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Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

ABBREVIATIONS:

Related collections

Genome Engineering using CRISPR

Most cited references 54

Responsiveness of the numeric pain rating scale in patients with low back pain.

Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort.

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