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

David W Polly, Daniel J Cher, Kathryn D Wine, Peter G Whang, Clay J Frank, Charles F Harvey, Harry Lockstadt, John A Glaser, Robert P Limoni, Jonathan N Sembrano, INSITE Study Group, John T Cummings Jr, John Swofford, Elizabeth Pertile, Ellen Looney, Jamie Edwards, Gordon Mortensen, Tracy Mente, Scott Kitchel, Christopher Miller, Gregory Moore, Shawn Potts, Robert Limoni, Nilesh Patel, Taylor McGinnis, Denise Barnes, Nicholas Peterson, Harry Lockstadt, Elaine Wilhite, James Farris, Don Kovalsky, Laura Pestka, Peter Whang, Donna Ann Thomas, Bethany Samperi, Stacey Lombardi, Emily A Darr, John A Glaser, Laura Fields, Jennifer Philp, Charles Harvey, Jason Peterman, Karim Bouferrache, Lori Latham, Pierce Nunley, Andrew Utter, Marcus Stone, Norma Rivera, Monicah Jepkemboi, Anthony Juarez, Ed Santos, David Polly, Jonathan Sembrano, Charles Ledonio, Sharon Yson, Philip Ploska, Terry Price, Michael Oh, Gary Schmidt, Matthew Yeager, Merle Stringer, Douglas Stringer, Carolyn Henderson, Farshad Ahadian, Yu-Po Lee, Gowriharan Thaiyananthan, Navid Farahmand, Tungie Williams, William Rosenberg, Pamela McCann, Vikas Patel, Scott Laker, Venu Akuthota, Evalina Burger, Christopher Kleck, Claire Cofer, David Calabrese, Mark C Gillespy, Sherri Zicker, Corinne Lee, Denise Law, Jeff Price, Shira Stone, Yadira Fortino, Terrill Himmelmann, Elaine Wilhite, David W Polly, Daniel J Cher, Kathryn D Wine, Peter G Whang, Clay J Frank, Charles F Harvey, Harry Lockstadt, John A Glaser, Robert P Limoni, Jonathan N Sembrano, INSITE Study Group, John T Cummings Jr, John Swofford, Elizabeth Pertile, Ellen Looney, Jamie Edwards, Gordon Mortensen, Tracy Mente, Scott Kitchel, Christopher Miller, Gregory Moore, Shawn Potts, Robert Limoni, Nilesh Patel, Taylor McGinnis, Denise Barnes, Nicholas Peterson, Harry Lockstadt, Elaine Wilhite, James Farris, Don Kovalsky, Laura Pestka, Peter Whang, Donna Ann Thomas, Bethany Samperi, Stacey Lombardi, Emily A Darr, John A Glaser, Laura Fields, Jennifer Philp, Charles Harvey, Jason Peterman, Karim Bouferrache, Lori Latham, Pierce Nunley, Andrew Utter, Marcus Stone, Norma Rivera, Monicah Jepkemboi, Anthony Juarez, Ed Santos, David Polly, Jonathan Sembrano, Charles Ledonio, Sharon Yson, Philip Ploska, Terry Price, Michael Oh, Gary Schmidt, Matthew Yeager, Merle Stringer, Douglas Stringer, Carolyn Henderson, Farshad Ahadian, Yu-Po Lee, Gowriharan Thaiyananthan, Navid Farahmand, Tungie Williams, William Rosenberg, Pamela McCann, Vikas Patel, Scott Laker, Venu Akuthota, Evalina Burger, Christopher Kleck, Claire Cofer, David Calabrese, Mark C Gillespy, Sherri Zicker, Corinne Lee, Denise Law, Jeff Price, Shira Stone, Yadira Fortino, Terrill Himmelmann, Elaine Wilhite

Abstract

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.

Figures

FIGURE 1
FIGURE 1
Physical examination tests for sacroiliac joint dysfunction. A, thigh thrust. B, flexion, abduction, and external rotation (FABER). C, pelvic gapping (distraction). D, compression. E, Gaenslen test.
FIGURE 2
FIGURE 2
Subject flow through the study, including crossover visits.
FIGURE 3
FIGURE 3
Change in visual analog scale (VAS) sacroiliac (SI) joint pain by visit. Dark thick lines show those assigned to nonsurgical management (NSM) or SI joint fusion. Dotted line indicates NSM subjects who crossed over to surgery. Thin solid line indicates those who did not cross over to surgery.
FIGURE 4
FIGURE 4
Change in Oswestry Disability Index (ODI) by visit. Dark thick lines show those assigned to nonsurgical management (NSM) or sacroiliac (SI) joint fusion. Dotted line indicates NSM subjects who crossed over to surgery. Thin solid line indicates those who did not cross over to surgery.
FIGURE 5
FIGURE 5
Improvement in Short Form-36 (SF-36) domains by treatment and visit. Values on the x axis values are slightly jittered. Green, sacroiliac joint (SIJ) fusion; blue, nonsurgical management (NSM); solid, baseline; dashed, 6 months; dotted (only SIJ fusion group shown), 12 months. BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RE, role emotional; RP, role physical; SF, social function; VT, vitality.
Figure
Figure
No available caption

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