Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Mar 6;101(5):400-411.
doi: 10.2106/JBJS.18.00022.

Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint

Julius Dengler  1   2   3 , Djaya Kools  4 , Robert Pflugmacher  5 , Alessandro Gasbarrini  6 , Domenico Prestamburgo  7 , Paolo Gaetani  8 , Daniel Cher  9 , Eddie Van Eeckhoven  10 , Mårten Annertz  11 , Bengt Sturesson  12
Affiliations
Randomized Controlled Trial

Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint

Julius Dengler et al. J Bone Joint Surg Am. .

Abstract

Background: Sacroiliac joint pain is increasingly recognized as a cause of low back pain. We compared the safety and effectiveness of minimally invasive sacroiliac joint arthrodesis using triangular titanium implants and conservative management in patients with chronic sacroiliac joint pain.

Methods: This study was a prospective, multicenter randomized controlled trial of adults with chronic sacroiliac joint pain assigned to either conservative management or sacroiliac joint arthrodesis with triangular titanium implants. The study end points included self-rated low back pain (visual analog scale [VAS]), back dysfunction (Oswestry Disability Index [ODI]), and quality of life. Ninety percent of subjects in both groups completed the study.

Results: Between June 6, 2013, and May 15, 2015, 103 subjects were randomly assigned to conservative management (n = 51) or sacroiliac joint arthrodesis (n = 52). At 2 years, the mean low back pain improved by 45 points (95% confidence interval [CI], 37 to 54 points) after sacroiliac joint arthrodesis and 11 points (95% CI, 2 to 20 points) after conservative management, with a mean difference between groups of 34 points (p < 0.0001). The mean ODI improved by 26 points (95% CI, 21 to 32 points) after sacroiliac joint arthrodesis and 8 points (95% CI, 2 to 14 points) after conservative management, with a mean difference between groups of 18 points (p < 0.0001). Parallel improvements were seen in quality of life. In the sacroiliac joint arthrodesis group, the prevalence of opioid use decreased from 56% at baseline to 33% at 2 years (p = 0.009), and no significant change was observed in the conservative management group (47.1% at baseline and 45.7% at 2 years). Subjects in the conservative management group, after crossover to the surgical procedure, showed improvements in all measures similar to those originally assigned to sacroiliac joint arthrodesis. In the first 6 months, the frequency of adverse events did not differ between groups (p = 0.664). By month 24, we observed 39 severe adverse events after sacroiliac joint arthrodesis, including 2 cases of sacroiliac joint pain, 1 case of a postoperative gluteal hematoma, and 1 case of postoperative nerve impingement. The analysis of computed tomographic (CT) imaging at 12 months after sacroiliac joint arthrodesis showed radiolucencies adjacent to 8 implants (4.0% of all implants).

Conclusions: For patients with chronic sacroiliac joint pain due to joint degeneration or disruption, minimally invasive sacroiliac joint arthrodesis with triangular titanium implants was safe and more effective throughout 2 years in improving pain, disability, and quality of life compared with conservative management.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Patient flow. SIJA = sacroiliac joint arthrodesis, CM = conservative management, FU = follow-up, m = month, X-over = crossover, and LTFU = lost to FU.
Fig. 2
Fig. 2
Change in VAS low back (LB) pain, VAS leg pain, ODI, EQ-5D time trade-off (TTO), EQ-5D VAS, and Zung Depression Scale scores. Blue indicates the conservative management group, and green indicates the sacroiliac joint arthrodesis group. The last-observation-carried-forward method was used to estimate values after crossover. The values shown are the mean. The error bars indicate the 95% CI.
Fig. 3
Fig. 3
Change in functional test (active straight leg raise test) by treatment and time (left) and the number of positive physical examination signs (right). Blue indicates the conservative management group, and green indicates the sacroiliac joint arthrodesis group. The solid line indicates the right sacroiliac joint affected, and the dotted line indicates the left sacroiliac joint affected. The last-observation-carried-forward method was used to estimate values after crossover. The values shown are the mean. The error bars indicate the 95% CI.
Fig. 4
Fig. 4
Proportion of subjects reporting opioid use in the past 2 weeks by treatment and study visit. Blue indicates the conservative management (CM) group, and green indicates the sacroiliac joint arthrodesis (SIJA) group.
Fig. 5-A
Fig. 5-A
Change in walking distance and ambulatory status.
Fig. 5-B
Fig. 5-B
Change in work status and comparison with baseline.
Fig. 5-C
Fig. 5-C
Change in satisfaction and desirability of having a surgical procedure again by treatment and follow-up visit.
Fig. 6
Fig. 6
Change in VAS low back (LB) pain, VAS leg pain, ODI, Zung Depression Scale, EQ-5D time trade-off (TTO), and EQ-5D VAS scores including subjects who crossed over from conservative management to sacroiliac joint arthrodesis. Green indicates the subjects initially assigned to sacroiliac joint arthrodesis, blue indicates subjects assigned to the conservative management group prior to crossover, and gray indicates conservative management subjects who crossed over to surgical treatment with the sacroiliac joint arthrodesis group after the 6-month visit. The values shown are the mean. The error bars indicate the 95% CI.
Fig. 7
Fig. 7
Imaging of typical configuration of implants. Fig. 7-A Inlet-view pelvic radiograph. Fig. 7-B A 12-month CT image from a different subject showing no radiolucencies around the first implant. Fig. 7-C A 12-month CT image from another subject showing radiolucency around the second implant in the sacrum.
Fig. 8
Fig. 8
A 12-month CT image depicting bilateral implants with bone apposition along the entire length of the superior and inferior sides of both implants. Also, there is bone overgrowth at the outer iliac cortex (the left side is greater than the right side), suggesting complete implant integration into the ilium. However, there is little bone apposition along the implants within the joint.
See this image and copyright information in PMC

Comment in

References

    1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fèvre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O’Donnell M, O’Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA, 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leòn FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012. December 15;380(9859):2163-96. - PMC - PubMed
    1. Hudson TJ, Edlund MJ, Steffick DE, Tripathi SP, Sullivan MD. Epidemiology of regular prescribed opioid use: results from a national, population-based survey. J Pain Symptom Manage. 2008. September;36(3):280-8. Epub 2008 Jul 10. - PMC - PubMed
    1. Volkow ND. America’s addiction to opioids: heroin and prescription drug abuse. 2014. May 14 https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to.... Accessed 2018 Oct 15.
    1. Bernard TN, Jr, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987. April;217:266-80. - PubMed
    1. Sembrano JN, Polly DW., Jr How often is low back pain not coming from the back? Spine (Phila Pa 1976). 2009. January 1;34(1):E27-32. - PubMed

Publication types

MeSH terms