Elsevier

The Spine Journal

Volume 16, Issue 11, November 2016, Pages 1324-1332
The Spine Journal

Clinical Study
Postoperative complications in patients undergoing minimally invasive sacroiliac fusion

https://doi.org/10.1016/j.spinee.2016.06.016Get rights and content

Abstract

Background Context

Minimally invasive sacroiliac (SI) joint fusion has become increasingly relevant in recent years as a treatment for SI joint pathology. Previous studies have found minimally invasive SI fusion to be an effective and safe treatment option for chronic SI joint pain. However, these studies have been primarily single-center, case-based, or manufacturer-sponsored investigations, and as such their findings are limited to their sample populations.

Purpose

The aim of this study was to investigate the safety of minimally invasive SI fusion using a large nationwide sample group to more accurately identify complication rates of this increasingly popular procedure.

Study Design/Setting

This is a retrospective database study.

Patient Sample

The sample includes patients within the orthopedic subset of Humana database who underwent minimally invasive SI fusion between 2007 and 2014.

Outcome Measures

Complications and novel lumbar and nerve pathology were the outcome measures.

Methods

Patients undergoing minimally invasive SI fusion from 2007 to 2014 were identified using the Pearl Diver patient record database (Pearl Diver Technologies, West Conshohocken, PA, USA) from the nationwide private insurance provider Humana Inc. This approach provided access to records of over 18 million patients in every major geographic region of the country. Using the ICD-9 diagnosis codes (International Classification of Diseases 9th edition), data from patient records were analyzed to reveal incidence of postoperative infection, pain, osteomyelitis, joint derangement, urinary tract infection, and novel lumbar and nervous system pathology.

Results

Four hundred sixty-nine patients (305 female; 164 male) within the Humana insurance database received minimally invasive SI fusion between 2007 and 2014. Data from these patients showed a substantial increase in the use of the procedure over this 7-year period. Among these patients, an overall complication rate of 13.2% (n=62) was seen at 90 days postoperatively and 16.4% (n=77) at 6 months. The number of patients receiving a first time diagnosis of lumbar pathology following minimally invasive SI fusion in the sample population was also analyzed. The incidence of novel lumbar pathology in this population was 3.6% (n=17) at 90 days postoperatively and 5.3% (n=25) at 6 months. Men experienced diagnoses of novel lumbar pathology at higher rates than women within both 90 days (men=6.7%; women≤3.3%) and 6 months (men=9.1%; women≤3.3%) of the procedure (p<.01).

Conclusions

The results of this study show that minimally invasive SI joint fusion could possibly carry higher risks of complications than previously stated. These findings are useful for physicians and patients when considering treatment for chronic SI joint pain.

Introduction

Minimally invasive sacroiliac (SI) fusion has become an increasingly popular treatment for non-traumatic SI joint pain in the United States in recent years [1]. Using a system of percutaneous implants to stabilize the SI joint, the procedure offers a surgical option for patients with chronic SI joint pain who have exhausted less invasive treatment options. Sacroiliac joint pain has been well documented as the underlying cause of 15% to 30% of lower back pain cases in the United States [2], [3], [4], [5], [6]. Lower back pain is one of the top three causes of chronic pain in developed countries and costs the US economy an estimated $60 to 100 billion annually [7], [8], [9], [10]. Establishing a safe and effective treatment option for SI joint pathology has the potential to make an enormous positive impact on the quality of life in the United States.

Traditionally, open SI arthrodesis has been an option for treating SI pain when non-surgical treatments such as physical therapy, SI joint injections, non-steroidal anti-inflammatory drugs, and medical pain management have failed [11]. However, the use of this procedure has been limited because of the risks involved with large incision, bone harvesting, long hospital stay, and damage to pelvic structures [12], [13], [14], [15], [16]. The development of the percutaneous minimally invasive SI fusion technique was first reported in 2004 and has sought to reduce these risks to make SI fusion a viable treatment option for SI joint pain [11], [17], [18]. Numerous studies have been published in recent years reporting minimally invasive SI fusion to be effective in treating SI joint pain [11], [18], [19], [20], [21], [22]. Many of these studies have shown adverse events and low reoperation rates when compared with the open procedure, and report a high degree of patient satisfaction using the new minimally invasive technique [17], [18], [21], [22]. Minimally invasive SI fusion has also been shown to decrease treatment costs for SI joint pain, with a potential savings to the US Medicare system of $660 million over the course of the patient's lifetime [23]. Possibly as a result of this combination of factors, minimally invasive SI fusion has become a widely used technique: In 2012, more than 87% of all SI arthrodesis performed by polled surgeons from the International Society for the Advancement of Spinal Surgery (ISASS) and Society for Minimally Invasive Spine Surgery (SMISS) were minimally invasive, and based on trends in recent years today this number is likely even higher [1].

This increased use of minimally invasive SI fusion to treat SI joint pathology has created the need for reliable data addressing the safety of the procedure. Existing literature has largely failed to sufficiently address this issue. Most studies have focused primarily on efficacy and patient satisfaction, and those that have attempted to address the issue of safety have lacked sample sizes large enough to reliably do so [2], [18], [20], [22], [24]. Primarily, this has been due to the fact that minimally invasive SI is a relatively new procedure, and as a result acquiring a large sample population for a study can be difficult. Additionally, the majority of existing studies are case series, and as such their findings are limited to their sample populations. The aim of this study was to analyze trends of SI fusion complications using a large nationwide patient population to more accurately identify complication rates of this increasingly popular procedure.

Section snippets

Materials and methods

Evidence & Methods

Context

While there has recently been increased enthusiasm regarding the use of sacroiliac (SI) fusion for the treatment of disorders involving this joint, reports of its utility and complication profile are largely derived from single centers and small centers. To evaluate the incidence, prevalence and complication profile in a larger series of patients treated over a 7-8 year period through Humana insurance programs.

Contribution

The authors study included 469 patients. The

Results

The Humana private insurance database composed of 18,620,198 patient records from every major geographic region of the country (Northeast, South, Midwest, and West) was searched systematically using the Pearl Diver database. The search returned information on 469 patients who underwent SI fusion from 2007 to 2014. Of these patients, 65% (305) were women and 35% (164) were men. The obtained data showed an increase in the number of SI fusion procedures performed annually during the 8-year period

Discussion

The results of our study show higher overall complication rates for minimally invasive SI fusion than have been previously reported, as well as a significant increase in the number of patients undergoing the procedure in recent years.

Many of the previous studies on minimally invasive SI fusion have focused primarily on analyzing the effectiveness of the new procedure. As a result, outcome has been the primary line of inquiry and few have addressed safety using an adequate approach. Those that

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      Therefore, it seems that nerve impingements caused by implant misplacement are one of the main challenges associated with MISJF. With respect to other complications, Schoell et al.56 reported novel lumbar disease as a complication in 3.5% and 5.3% of patients undergoing MISJF 90 days and 6 months after surgery, respectively. The iMIA trial (NCT01741025) reported 2 patients who experienced recurrent SIJ pain caused by possible device loosening in the sacrum, 1 patient who had a new onset leg pain caused by implant malposition, and 1 patient with a postoperative hematoma.

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    • Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium versus Cylindrical Threaded Implants: A Comparison of Patient-Reported Outcomes

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      There remains a need for further examination of postoperative complications. Although not a goal of this study, further attention should be given as complication rates have been seen as high as 16% in the iFuse system and as high as 52% in the CTI system.31-33 As with many other peer-reviewed publications describing SI joint fusion, this study is limited by the lack of radiographic evaluation of fusion.

    • Endoscopic Surgical Technique for Treating Sacral Radiculopathy Secondary to S1 Nerve Compression After Minimally Invasive Sacroiliac Joint Fusion: Technical Note

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      Many publications on minimally invasive SI fusion focus on the effectiveness of the procedure, not on the complications associated with the procedure. The complication rates associated with the procedure seem to vary from 16.4% in 1 study with an n = 77 patients5 to 18% in another study with an n = 114 patients,6 to a range of 3.5%−5.6% (n = 5319 patients) in an industry-sponsored study.7 The specific complication of nerve impingement has been reported in 1 case by Araghi et al8 (n = 50 patients), 48 cases by Miller et al (n = 5319 patients),7 and 3 patients by Smith et al (n = 113 patients).6

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    FDA device/drug status: Not applicable.

    Author disclosures: KS: Nothing to disclose. ZB: Consultancy: Xenco Medical (B). AJ: Nothing to disclose. MP: Nothing to disclose. NNP: Nothing to disclose. PCH: Consulting: Medtronic (E), DePuy Synthes (D), outside the submitted work. JCL: Nothing to disclose. JCW: Royalties: Aesculap (B), Biomet (G), Amedica (C), SeaSpine (D), Synthes (C), outside the submitted work; Stock Ownership: FzioMed (less than 1%), outside the submitted work; Private Investments: Promethean Spine (less than 1% of entity), Paradigm Spine (less than 1% of entity), Benevenue (less than 1% of entity), NexGen (less than 1% of entity), VertiFlex (less than 1% of entity), ElectroCore (less than 1% of entity), Surgitech (less than 1% of entity), CoreSpine (less than 1% of entity), Expanding Orthopaedics (less than 1% of entity), Osprey (less than 1% of entity), Bone Biologics (less than 1% of entity), Curative Biosciences (less than 1% of entity), Pearl Diver (less than 1% of entity), outside the submitted work; Board of Directors: North American Spine Society (Non-financial, reimbursement for travel for board meetings, courses, etc.), North American Spine Foundation (Nonfinancial), Cervical Spine Research Society (Nonfinancial, reimbursement for travel for board meetings), AOSpine/AO Foundation (E, honorariums for board position), outside the submitted work; Fellowship Support: AO Foundation (E, Spine fellowship funding, Paid directly to institution/employer), outside the submitted work.

    The disclosure key can be found on the Table of Contents and at www.TheSpineJournalOnline.com.

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