Populations	Interventions	Comparators	Outcomes
Individuals: · With sacroiliac joint pain	Interventions of interest are: · Sacroiliac joint fusion/fixation with a triangular implant	Comparators of interest are: · Conservative therapy	Relevant outcomes include: · Symptoms · Functional outcomes · Quality of life · Medication use · Treatment-related morbidity
Individuals: · With sacroiliac joint pain	Interventions of interest are: · Sacroiliac joint fusion/fixation with a cylindrical threaded implant	Comparators of interest are: · Conservative therapy	Relevant outcomes include: · Symptoms · Functional outcomes · Quality of life · Medication use · Treatment-related morbidity

Background

Sacroiliac Joint Pain
Similar to other structures in the spine, it is assumed that the sacroiliac joint (SIJ) may be a source of low back pain. In fact, before 1928, the SIJ was thought to be the most common cause of sciatica. In 1928, the role of the intervertebral disc was elucidated, and from that point forward, the SIJ received less research attention.

Diagnosis
Research into SIJ pain has been plagued by lack of a criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, SIJ pain is typically without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for SIJ pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding study of the SIJ is that multiple structures, (eg, posterior facet joints, lumbar discs) may refer pain to the area surrounding the SIJ.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy (see separate policy on 'Prolotherapy' - Policy #063 in the Treatment Section), corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. Some procedures have been referred to as SIJ fusion but may be more appropriately called fixation (this is because there is little to no bridging bone on radiographs). Devices for SIJ fixation/fusion that promote bone ingrowth to fixate the implants include a triangular implant (iFuse Implant System) and cylindrical threaded devices (Rialto, SImmetry, Silex, SambaScrew, SI-LOK). Some devices also have a slot in the middle where autologous or allogeneic bone can be inserted. This added bone is intended to promote fusion of the SIJ.

Regulatory Status
A number of percutaneous or minimally invasive fixation/fusion devices have been cleared for marketing by the FDA through the 510(k) process. They include the iFuse® Implant System (SI Bone), the Rialto™ SI Joint Fusion System (Medtronic), SIJ-Fuse (Spine Frontier), the SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies), Silex™ Sacroiliac Joint Fusion System (XTANT Medical), SambaScrew® (Orthofix), and the SI-LOK® Sacroiliac Joint Fixation System (Globus Medical). FDA product code: OUR.

Related Policies

• Prolotherapy (Policy #063 in the Treatment Section)
• Percutaneous Vertebroplasty and Sacroplasty (Policy #029 in the Treatment Section)
• Radiofrequency Joint Ablation/Denervation (Policy #158 in the Treatment Section)
• Sacroiliac Joint Injections (Policy #108 in the Treatment Section)
• Sacroiliac Joint Arthrography (Policy #015 in the Radiology Section)

1. Minimally invasive fixation/fusion of the sacroiliac joint using a titanium triangular implant is considered medically necessary when ALL of the following criteria have been met:

· Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; AND
· There is an absence of generalized pain behavior (eg, somatoform disorder) or generalized pain disorders (eg, fibromyalgia); AND
· Member has undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program; AND
· Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior sacroiliac joint, and consistent with sacroiliac joint pain; AND
· A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere; AND
· There is a positive response to a cluster of 3 provocative tests (eg, thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); AND
· Diagnostic imaging studies include ALL of the following:
o Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of the sacroiliac joint excludes the presence of destructive lesions (eg, tumor, infection) or inflammatory arthropathy of the sacroiliac joint; AND
o Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; AND
o Imaging of the lumbar spine (computed tomography or magnetic resonance imaging) is performed to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; AND
o Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration; AND
· There is at least a 75% reduction in pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular sacroiliac joint injection on 2 separate occasions; AND
· A trial of a therapeutic sacroiliac joint injection (ie, corticosteroid injection) has been performed on at least once.

Conservative nonsurgical therapy for the duration specified should include the following:

· Use of prescription strength analgesics for several weeks at a dose sufficient to induce a therapeutic response
o Analgesics should include anti-inflammatory medications with or without adjunctive medications such as nerve membrane stabilizers or muscle relaxants AND
· Participation in at least 6 weeks of physical therapy (including active exercise) or documentation of why the patient could not tolerate physical therapy, AND
· Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues
· Documentation of patient compliance with the preceding criteria.

SIJ FUSION/FIXATION WITH A TRIANGULAR IMPLANT SYSTEM

Clinical Context and Test Purpose
The purpose of SIJ fusion/fixation with a triangular implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of SIJ fixation/fusion with a triangular implant improve the net health outcome in individuals with SIJ pain?

The following PICOTS were used to select literature to inform this review.

Patients
The relevant population of interest is individuals with SIJ pain.

Interventions
The therapy being considered is SIJ fixation/fusion with a triangular implant.

Comparators
The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes
The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, quality of life, reductions in medication use, and treatment-related morbidity.

Timing
Follow-up from 1 to 5 years is of interest to monitor outcomes.

Setting
Patients with SIJ pain are actively managed by spine or musculoskeletal specialists, rheumatologists, and primary care providers in an outpatient setting.

Study Selection Criteria
Methodologically credible studies were selected using the principles outlined in indication 2.

Randomized Controlled Trials

INSITE
Whang et al (2015) reported an industry-sponsored nonblinded RCT, Investigation of Sacroiliac Fusion Treatment (INSITE) of the iFuse Implant System in 148 patients. The 12-month follow-up to this RCT was reported by Polly et al (2015), and 2-year follow-up was reported by Polly et al (2016). However, by 12 months, almost all patients in the control group had crossed over to SIJ fusion, precluding a comparison between groups. Trial inclusion was based on a determination of the SIJ as a pain generator from a combination of a history of SIJ-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in SIJ pain after image-guided local anesthetic injection into the SIJ. Trial characteristics are summarized in Table 1. The duration of pain before enrollment averaged 6.4 years (range, 0.47-40.7 years). A large proportion of subjects (37%) had previously undergone lumbar fusion, SIJ steroid injections (86%), and RFA (16%).

Patients were randomized 2:1 to minimally invasive SIJ fusion (n=102) or to nonsurgical management (n=46). Nonsurgical management included a stepwise progression of nonsurgical treatments, depending on individual patient choice. During follow-up, control patients received physical therapy (97.8%), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). The primary outcome measure was the 6-month success rate, defined as the proportion of treated subjects with a 20-mm improvement in SIJ pain in the absence of severe device-related or neurologic adverse events or surgical revision. Patients in the control arm could crossover to surgery after 6 months. Baseline scores indicated that the patients were severely disabled, with VAS pain scores averaging 82.3 out of 100, and ODI scores averaging 61.9 out of 100 (0=no disability, 100=maximum disability).

Results from the INSITE trial are shown in Table 2. At 6 months, success rates were 23.9% in the control group vs 81.4% in the surgical group (posterior probability of superiority >0.999). A clinically important (≥15-point) improvement in ODI score was found in 27.3% of controls compared with 75.0% of fusion patients. Measures of quality of life (36-Item Short-Form Health Survey, EuroQol-5D) also improved to a greater extent in the surgery group. Of the 44 nonsurgical management patients still participating at 6 months, 35 (79.5%) crossed over to fusion. Compared with baseline, opioid use at 6 months decreased from 67.6% to 58% in the surgery group and increased from 63% to 70.5% in the control group (p=0.082). At 12 months, opioid use was similar between groups (55% vs 52%, p=0.61).

Polly et al (2016) reported 2-year outcomes from the SIJ fusion arm of this RCT (see Table 3). Of 102 subjects originally assigned to SIJ fusion and treated, 89 (87%) were evaluated at 2 years. In this report, clinical outcomes were based on the amount of improvement in SIJ pain and in ODI scores. The improvement was defined as a change of 20 points in SIJ pain score and 15 points in ODI score. Substantial improvement was defined as a change of 25 points in SIJ pain score—or an SIJ pain score of 35 or less—and an improvement of 18.8 points in ODI score. At 24 months, 83.1% had improvements in SIJ pain score, and 68.2% had improvements in ODI scores. By 24 months, the proportion taking opioids was reduced from 68.6% at baseline to 48.3%.

Three-year follow-up results of the INSITE and Sacroiliac Joint Fusion with iFuse Implant System trials were published by Darr et al (2018). Of 103 patients with SIJ dysfunction who were treated with minimally invasive SIJ fusion with triangular titanium implants, 60 (72.3%) patients reported an improvement in ODI scores of at least 15 points from baseline to 3 years. The mean ODI score decreased from 56 to 28 for the same timeframe, an improvement of 28 points (p<0.001); similarly, the mean SIJ pain score decreased to 26.2, reflecting a decrease of 55 points (p<0.001). Over 3 years of follow-up, 168 adverse events were reported in 75 patients, although only 22 of these events involved the pelvis. The study was limited by its lack of long-term data from a control group not receiving surgical treatment.

iMIA
In 2016 and 2017, the iFuse Implant System Minimally Invasive Arthrodesis (iMIA) study group reported another industry-sponsored multicenter RCT of the iFuse Implant System in 103 patients. Selection criteria were similar to those of the trial by Whang et al (2015), including at least a 50% pain reduction on SIJ block. The mean pain duration was 4.5 years, and about half of the patients were not working due to lower back pain. Additionally, 33% of patients had undergone prior lumbar fusion. Nonsurgical management included physical therapy and exercises at least twice per week; interventional procedures (eg, steroid injections, RFA) were not allowed. The primary outcome was change in VAS pain score at 6 months.

All patients assigned to iFuse underwent the procedure, and follow-up at 6 months was available for 49 of 51 patients in the control group and for all 52 patients in the iFuse group. Six-month results as reported by Sturesson et al (2016) are shown in Table 2. At 6 months, VAS pain scores improved by 43.3 points in the iFuse group and by 5.7 points in the control group (p<0.001). ODI scores improved by 25.5 points in the iFuse group and by 5.8 points in the control group (p<0.001, between groups). An improvement in lower back pain by at least 20 VAS points (minimal clinically important difference) was achieved in 78.8% of the SIJ fusion group vs 22.4% of controls; p<0.001). Quality of life outcomes showed a greater improvement in the iFuse group than in the control group. Changes in pain medication use were not reported. Patients in the conservative management group were allowed to cross over to SIJ fusion at 6 months.

Twelve-month results from the iMIA trial were reported by Dengler et al (2017) (see Table 3). Twenty-one patients in the conservative management group had little or no improvement in symptoms and crossed over to SIJ fusion after the 6-month visit. Fourteen (56%) of the 25 patients who remained in the conservative management group had at least a 20-point improvement in VAS back pain score (22.4% of patients assigned to conservative management). At 12 months, low back pain had improved by 42 points (standard deviation [SD], 27.0) on a 100-point VAS in the SIJ fusion group compared with 14 points (SD=33.4) in the conservative management group (p<0.001). Mean ODI scores improved by 25 points in the SIJ fusion group compared with 8.7 points in controls (p<0.001).

Table 1. Summary of Key RCT Characteristics

Study; Trial	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
Whang et al (2015); INSITE	U.S.	19	2013-2014	Patients 21-70 y with confirmed diagnosis of unilateral or bilateral SIJ dysfunction due to degenerative sacroiliitis and/or SIJ disruption	102 randomized to SIJ fusion	46 randomized to nonsurgical management
Sturesson et al (2017); iMIA	EU (Belgium, Germany, Italy, Sweden)	9	2013-2015	Patients 21-70 y with LBP for >6 mo and diagnosed with SIJ as primary pain generatora	52 randomized to SIJ fusion	51 randomized to conservative management

LBP: low back pain; RCT: randomized controlled trial; SIJ: sacroiliac joint.
^a The 3 criteria for diagnosis of SIJ pain were as follows: pain was present or near the posterior superior iliac spine; there were at least 3 positive findings on 5 provocative tests; at least a 50% pain reduction on fluoroscopically guided injection of local anesthetic into the joint.

Table 2. Summary of 6-Month iFuse Results From INSITE and iMIA

Results	VAS Score		Success End Point		ODI Score		SF-36 PCS Score		EQ-5D TTO Index
	Ctl	iFuse	Ctl	iFuse	Ctl	iFuse	Ctl	iFuse	Ctl	iFuse
INSITE
Baseline	82.2	82.3			61.1	62.2	30.8	30.2	0.47	0.44
Follow-up	70.4	29.8	23.9%	81.4%a	56.4	31.9	32.0	42.8	0.52	0.72
Change	-12.1	-52.6a			-4.9	-30.3a	1.2	12.7	0.05	0.29
iMIA
Baseline	73.0	77.7
Follow-up	67.8	34.4
Change	-5.7	-43.3			-5.8	-25.5			0.11	0.37

Adapted from Whang et al (2015) and Sturesson et al (2015).
The success end point was defined as a reduction in VAS pain score of ≥20, absence of device-related events, absence of neurologic worsening, and absence of surgical intervention.
Ctl: control; EQ-5D TTO Index: EuroQoL Time Tradeoff Index; ODI: Oswestry Disability Index; SF-36 PCS: 36-Item Short-Form Health Survey Physical Component Summary; VAS: visual analog scale.
^a p<0.001.

Table 3. Extended Follow-Up From the INSITE and iMIA Trials

Outcome Measures	Baseline (SD)	6 Months (SD)	12 Months (SD)	24 Months (SD)
INSITE
Sacroiliac joint fusion pain score	82.3	29.8		26.7
Percent ≥20-point improvement pain				83.1%
Sacroiliac joint fusion ODI score	57.2	31.9		28.7
% ≥15-point improvement ODI				68.2%
iMIA
Low back pain
Conservative management	73.0 (13.8)	67.8 (20.3)	58.9 (28.2)
Sacroiliac joint fusion	77.7 (11.3)	34.4 (23.9)	35.2 (25.5)
Leg pain
Conservative management	47.1 (31.1)	46.5 (31.4)	41.7 (32.4)
Sacroiliac joint fusion	52.7 (31.5)	22.6 (25.1)	24.0 (27.8)
ODI
Conservative management	55.6 (13.7)	50.2 (17.2)	46.9 (20.8)
Sacroiliac joint fusion	57.5 (14.4)	32.0 (18.4)	32.1 (19.9)

Adapted from Dengler et al (2017).
ODI: Oswestry Disability Index; SD: standard deviation.

Tables 4 and 5 display notable gaps identified in each study.

Table 4. Relevance Gaps

Study; Trial	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-Upe
Whang et al (2015); INSITE
Sturesson et al (2017); iMIA	1. Patients with other contributory sources of LBP might have been enrolled with SIJ-caused LBP patients

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
LBP: low back pain; SIJ: sacroiliac joint.
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 5. Study Design and Conduct Gaps

Study; Trial	Allocationa	Blindingb	Selective Reportingd	Data Completenesse	Powerd	Statisticalf
Whang et al (2015); INSITE
Sturesson et al (2017); iMIA		1. Intervention was unblinded

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Subsection Summary: Randomized Controlled Trials
Two RCTs have reported outcomes past 6 months, after which crossover was allowed. Both studies reported significantly greater reductions in VAS pain scores and ODI scores in SIJ fusion patients than in control groups. The reductions in pain and disability observed in the SIJ fusion group at 6 months were maintained out to 1 year compared with controls who had not crossed over. The RCTs were nonblinded without a placebo or an active control group. However, pain has a significant subjective and psychologic component. Cognitive behavioral techniques to address pain were specifically excluded from the types of treatment that control subjects could obtain. Thus, as relates to trial design, an independent assessment of pain outcomes would have been preferable.

Nonrandomized Studies
Prospective cohort studies with good follow-up rates are more likely to provide valid estimates of outcomes. Principal results of the studies at 2- to 3-year follow-up are shown in Table 6.

Results from a cohort of 172 patients undergoing SIJ fusion reported to 2 years were published by Duhon et al (2016). Patients were formally enrolled in a single-arm trial (NCT01640353) with planned follow-up for 24 months. Success was defined as a reduction of pain score of 20-mm on a 100-mm VAS, absence of device-related adverse events, absence of neurologic worsening, and absence of surgical reintervention. Enrolled patients had a mean VAS pain score of 79.8, a mean ODI score of 55.2, and a mean pain duration of 5.1 years. At 6 months, 136 (80.5%) of 169 patients met the success end point, which met the prespecified Bayesian probability of success rate. Mean VAS pain scores were 30.0 at 6 months and 30.4 at 12 months. Mean ODI scores were 32.5 at 6 months and 31.4 at 12 months. At 2 years, 149 (87%) of 172 patients were available for follow-up. The VAS pain score at 2 years was 26.0, and the ODI score was 30.9. Thus, 1-year outcomes were maintained at 2 years. Other outcomes (eg, quality of life scores) showed similar maintenance or slight improvement compared with 1-year outcomes. Use of opioid analgesics decreased from 76.2% at baseline to 55% at 2 years. Over the 2-year follow-up, 8 (4.7%) patients required revision surgery.

Table 6. Two- to 3-Year Outcomes of the iFuse Implant in Cohorts and Case Series

Studies and Outcomes	Mean Baseline Value	Mean 2- to 3-Year Value	Difference or % Achieving Outcome	Follow-Up Rate
Duhon et al (2016)
Pain score (range, 0-100)	79.8	26.0	53.3	86.6% (149/172)
Oswestry Disability Index score	55.2	30.9	24.5
SF-36 score	31.7	40.7	8.9
EQ-5D TTO score	0.43	0.71	0.27
Sachs et al (2016)
Pain score (range 0-10)	7.5	2.5
Oswestry Disability Index score		28.2

All differences between baseline and 2- to 3-year values were statistically significant.
EQ-5D TTO Index: EuroQoL Time Tradeoff Index; SF-36: 36-Item Short-Form Health Survey.

Nonrandomized Comparative Studies
Two retrospective nonrandomized comparative studies have been published. Vanaclocha et al (2018) found greater pain relief with SIJ fusion than with conservative management or SIJ denervation. Spain and Holt (2017) reported a retrospective review of surgical revision rates following SIJ fixation with either surgical screws or the iFuse triangular implant. Revision rates were lower with the iFuse device than observed with surgical screws.

Subsection Summary: Nonrandomized Studies
In general, cohort studies and case series have shown improvements in VAS pain scores and other outcomes measures consistent in magnitude to the RCTs. The subset of studies with good (>85%) follow-up rates generally showed that short-term outcomes were maintained. Two studies of reasonable sample size with good follow-up showed results maintained to 2 years. One study with a small sample size and good follow-up showed results maintained to 5 years. Improved health outcomes are also supported by retrospective studies that compare SIJ fusion/fixation using a triangular implant with other treatments for SIJ pain. These results are consistent with the medium-term durability of treatment. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and cumulative revision rate at 4 years of 3.54%.

Section Summary: SIJ Fusion/Fixation With a Triangular Implant
The evidence on SIJ fusion/fixation with a triangular implant includes 2 nonblinded RCTs of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be an independent blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer term follow-up from these RCTs has indicated that the results obtained at 6 months persist to 2 years. An additional cohort study and case series with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%) also showed reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%.

SIJ FUSION/FIXATION WITH A CYLINDRICAL THREADED IMPLANT

Clinical Context and Test Purpose
The purpose of SIJ fixation/fusion with a cylindrical threaded implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of SIJ fixation/fusion with a cylindrical threaded implant improve the net health outcome in individuals with SIJ pain?

The following PICOTS were used to select literature to inform this review.

Patients
The relevant population of interest is individuals with SIJ pain.

Interventions
The therapy being considered is SIJ fixation/fusion with a cylindrical threaded implant.

Comparators
The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes
The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, quality of life, reductions in medication use, and treatment-related morbidity.

Timing
Follow-up of 2 years is of interest to monitor outcomes.

Setting
Patients with SIJ pain are actively managed by spine or musculoskeletal specialists, rheumatologists, and primary care providers in an outpatient setting.

Study Selection Criteria
Methodologically credible studies were selected using the principles outlined in indication 2.

Systematic Reviews
Tran et al (2019) published a systematic review comparing the effectiveness of minimally invasive joint fusion (ie, utilizing the iFuse device) compared to screw-type surgeries.^44, A total of twenty studies was pooled to calculate a standardized mean difference across pain, disability, and global/quality-of-life outcomes, including 14 studies evaluation the iFuse system and 7 studies evaluated cylindrical, threaded implants. Studies evaluating cylindrical, threaded implants consisted of case series and cohort studies. Patients receiving these implants experienced significantly worse pain outcomes (p=0.03) compared to patients receiving iFuse, with a standardized mean difference of 1.28 (95% CI: 0.47 to 2.09) and 2.04 (95% CI: 1.76 to 2.33), respectively. A statistically significant difference in disability scores was reported between screw-type and iFuse implant groups (0.26 [95% CI: -1.90 to 2.41] vs 1.68 [95% CI: 1.43 to 1.94]; p=0.01), with improved outcomes in the iFuse population. For global/quality-of-life outcomes, a statistically significant difference in scores was reported between screw-type and iFuse implants groups (0.60 [95% CI: 0.33 to 0.88] vs 0.99 [95% CI: 0.75 to 1.24]; p=0.04), with improved outcomes in the iFuse population.

Prospective Studies
Rappoport et al (2017) reported on an industry-sponsored prospective study of SIJ fusion with a cylindrical threaded implant (SI-LOK). The study included 32 patients using a diagnosis of SIJ dysfunction who had failed nonoperative treatment, including medication, physical therapy, and therapeutic injections. A diagnostic injection was performed to confirm the source of pain to the SIJ. The procedure included drilling to prepare for screw insertion and implantation of 3 screws, at least one of which was slotted. The slotted screws were packed with an autogenous bone graft from the drill reamings. Pain and disability scores were reduced following device implantation (see Table 7), and revisions within the first 12 months of the study were low (n=2). Follow-up will continue through 2 years.

Araghi et al (2017) published interim results from an industry-sponsored prospective cohort study evaluating pain and ODI outcomes for patients treated for SIJ pain with the SImmetry system. For the 50 patients enrolled at the time of publication, the mean VAS score had decreased from 76.2 at baseline to 35.1 at 6 months after the procedure (p<0.001), with 36 (72%) patients achieving minimal clinically important difference (at least a 20-point reduction). The mean ODI score likewise showed significant improvement from baseline to 6 months, decreasing from 55.5 to 35.3 (p<0.001). Over half of the cohort (56% [n=28]) achieved the minimal clinically important difference (15-point reduction) on the ODI. Prior to surgery, 66% (n=33) of the cohort were on opioids, decreasing to 30% (n=15) at the 6-month follow-up (p<0.001). Quality of life was assessed with the EQ-5D time trade-off index: at baseline, the mean EQ-5D was 0.51, decreasing to 0.69 after 6 months (p<0.001). Likewise, improvements in the Physical and Mental Components Summary scores of the 36-Item Short-Form Health Survey were significantly improved at 6 months, compared with baseline. The strength of findings was limited by the small sample size and short follow-up; without full enrollment of 250 patients, the trial is underpowered to detect contributing factors to fusion and pain relief. Also, the trial does not have a control group. Follow-up data will be published at 1 and 2 years.

Case Series
Cross et al (2018) published a case series of 19 patients from 3 centers who underwent minimally invasive SIJ fusion with decortication, placement of bone graft, and fixation with threaded implants. At 12 months, bridging bone across the SIJ was observed in 79% (n=15) of patients, increasing to 94% (n=17 of 18 patients with data available) at 24 months. At 24 months postprocedure, 88% (n=15) had fusion within the decorticated area, and the same percentage of patients (88% [n=15]) had solid fusion. While the study was not powered to detect associations between radiographic fusion and clinical outcomes, the authors reported a significant change in the mean numeric rating scale score for pain, from preprocedure to 24-month follow-up: patients showed an average 73% reduction in low back pain (7.9/10 decreased to 2.1/10, p<0.01; effect size, -2.9). The industry-sponsored study had a small sample size, but provided follow-up data at 2 years after SIJ fusion with a threaded implant, indicating a need for larger comparative studies to confirm the favorable radiographic fusion results suggested by the study.

Table 7. Pain and Disability Scores After Implantation With a Cylindrical Threaded Implant

Outcome Measures	Baseline	3 Months (SD)	6 Months (SD)	12 Months (SD)	p
Low back pain	55.8 (26.7)	28.5 (21.6)	31.6 (26.9)	32.7 (27.4)	<0.01
Left leg pain	40.6 (29.5)	19.5 (22.9)	16.4 (25.6)	12.5 (23.3)	<0.01
Right leg pain	40.0 (34.1)	18.1 (26.3)	20.6 (25.4)	14.4 (21.1)	<0.05
Oswestry Disability Index	55.6 (16.1)	33.3 (16.8)	33.0 (16.8)	34.6 (19.4)	<0.01

Adapted from Rappoport et al (2017).
SD: standard deviation.

Section Summary: SIJ Fixation/Fusion With Cylindrical Threaded Implant
There is limited evidence on the fusion of the SIJ with devices other than the triangular implant. One-year results from a prospective cohort of 32 patients who received a cylindrical slotted implant showed reductions in pain and disability similar to results obtained for the triangular implant. However, there is uncertainty in the health benefit of SIJ fusion/fixation with this implant design. Therefore, controlled studies with a larger number of patients and longer follow-up are needed to evaluate this device.

Summary of Evidence
For individuals who have SIJ pain who receive SIJ fixation/fusion with a triangular implant, the evidence includes 2 nonblinded RCTs of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be independent, blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer term follow-up from these RCTs has indicated that the results obtained at 6 months persist to 2 years. An additional cohort study and case series, with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%), have also shown reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have SIJ pain who receive SIJ fusion/fixation with a cylindrical threaded implant, the evidence includes a prospective cohort. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The prospective cohort study will follow patients for 2 years following implantation of slotted screws filled with autologous bone. Results at 1 year are consistent with findings from the studies using a triangular implant. However, longer follow-up and controlled trials are needed to evaluate this type of implant. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clinical Input Responses

· “The evaluation of a patient for possible sacroiliac (SI) joint pain involves careful attention to a patient’s history and physical examination. When a patient’s symptoms and signs arouse sufficient clinical suspicion, additional tests are then required to confirm the diagnosis of SI joint dysfunction.” (AANS/CNS)
· “Proper SIJ pain diagnosis is key to appropriate patient management. There is an accepted diagnostic algorithm for SIJ pain that combines medical history, physical examination and confirmatory diagnostic SIJ block.” (ISASS)
· “The North American Spine Society’s coverage recommendations on SI joint fusion provides evidence-based criteria for diagnosing SI joint pain and selection criteria for surgical intervention.” (NASS/AAOS)
· “The North American Spine Society Criteria are the most respected and generally used criteria. Most patients with SI joint pain will respond to the conservative therapies listed. However, one criteria that I think should be added is a reduction in opioid use prior to the fusion.” (APS)
· “SI fusion is currently acceptable therapy in patients in whom significant response is noted with injection. SI joint fusion as part of the inferior portion of extensive thoracolumbar fusion (IE SI joint and pelvis) is an accepted approach. Increasing literature on the topic will enhance the knowledge base on this topic.” (Hospital of the University of Pennsylvania)
· “The only generally accepted objective criteria for the diagnosis of sacroiliac joint pain is response to image-guided sacro-iliac injections. Patients who do not respond to the injections generally do not improve with directed therapies. Patients who do improve with the injections will usually respond to fusion therapies.” (Hospital of the University of Pennsylvania)
· “Although criteria for the diagnosis of SI joint dysfunction is fairly well described, there is significant variability from study to study regarding the application of the diagnostic criteria. It is difficult to assess the efficacy of a treatment such as SI joint fusion when there is not a clearly defined and consistent manner of diagnosis from study to study. The vast majority of literature regarding outcomes following SI joint fusion surgery are low-quality retrospective studies, or small sample size prospective studies with limited follow-up.” (University Hospitals Cleveland Medical Center)
· “While the evidence is low, I agree with the NASS recommendations as outlined in their report particularly focusing on the fact that a patient has undergone and failed a minimum 6 months of intensive nonoperative treatments, the patient has a complaint and physical exam consistent with SIJ pain, imaging of the SI joint that excludes the presence of destructive lesions, at least 75% reduction of pain for the expected duration of the anesthetic used following an image- guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions and finally a successful trial of at least one therapeutic intra-articular SIJ injection with a corticosteroid.” (Vanderbilt University Medical Center)

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2017 Input
In response to requests, clinical input focused on sacroiliac joint (SIJ) fusion was received from 10 respondents, including 5 specialty society-level responses from 7 specialty societies (2 were joint society responses) and 5 physician-level responses from 4 academic centers while this policy was under review in 2017. Based on the evidence and independent clinical input, the clinical input supports that the following indication provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice:

· Use of fusion/stabilization of the SIJ using percutaneous and minimally invasive techniques for carefully selected patients as outlined in statements from the North American Spine Society.

2014 Input
In response to requests, input was received from 4 physician specialty societies and 4 academic medical centers (5 responses) while this policy was under review in 2014. Input was mixed on the use of arthrography, radiofrequency ablation, and fusion of the SIJ. Most reviewers considered injection for diagnostic purposes to be medically necessary when using controlled blocks with at least 75% pain relief, and for injection of corticosteroids for treatment purposes. Treatment with prolotherapy, periarticular corticosteroid, and periarticular botulinum toxin were considered investigational by most reviewers.

2010 Input
In response to requests, input was received from 4 physician specialty societies (6 responses) and 3 academic medical centers (5 responses) while this policy was under review in 2010. Input was mixed. There was general agreement that the evidence for SIJ injections is limited, although most reviewers considered sacroiliac injections to be the best available approach for diagnosis and treatment in defined situations.

Practice Guidelines and Position Statements

North American Spine Society
The North American Spine Society (NASS) published coverage recommendations for percutaneous sacroiliac joint (SIJ) fusion in 2015. NASS indicated that there was relatively moderate evidence. In the absence of high-level data, NASS policies reflect the multidisciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the United States. NASS recommended coverage when all of the following criteria are met:

1. “[Patients] have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program.
2. Patient’s report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain.
3. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, ie, at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (eg, greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist.
4. Positive response to a cluster of 3 provocative tests (eg, thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). Note that the thrust test is not recommended in pregnant patients or those with connective tissue disorders.
5. Absence of generalized pain behavior (eg, somatoform disorder) or generalized pain disorders (eg, fibromyalgia).
6. Diagnostic imaging studies that include ALL of the following:
a. Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (eg, tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion.
b. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.
c. Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain.
d. Imaging of the SI joint that indicates evidence of injury and/or degeneration.
7. At least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions.
8. A trial of at least one therapeutic intra-articular SIJ injection (ie, corticosteroid injection).”

American Society of Anesthesiologists et al
In 2010, the American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine updated their joint guidelines for chronic pain management. The guidelines recommended that “Diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of patients with suspected sacroiliac joint pain.” Based on opinions of consultants and society members, the guidelines recommend that “Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain.”

American Pain Society
The 2009 practice guidelines from the American Pain Society were based on a systematic review commissioned by the Society. The guidelines stated that there is insufficient evidence to evaluate validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy; the guidelines further stated that there is insufficient evidence to adequately evaluate benefits of SIJ steroid injection for nonradicular low back pain.

International Society for the Advancement of Spine Surgery
The International Society for the Advancement of Spine Surgery first published a policy statement on minimally invasive SIJ fusion in 2014. These recommendations were updated in a 2016 statement. Society recommendations indicated that patients who have all of the following criteria may be eligible for minimally invasive SIJ fusion:

· “Significant SI [sacroiliac] joint pain … or significantly limitations in activities of daily living because of pain from the SI joint(s).
· “SI joint pain confirmed with … at least 3 positive physical provocation examination maneuvers that stress the SI joint.
· “Confirmation of the SI joint as a pain generator with ≥ 75% acute decrease in pain immediately following fluoroscopically guided diagnostic intra-articular SI joint block using local anesthetic.
· “Failure to respond to at least 6 months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or … one or more of the following: … physical therapy…. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability;
· “Additional or alternative diagnoses that could be responsible for the patient’s ongoing pain or disability have been considered, investigated and ruled out.”

1.1 “Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure…. provided that standard arrangements are in place for clinical governance, consent and audit.
1.2 Patients having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.
1.3 This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain.”

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 8.

Table 8. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT01861899a	Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System	55	Nov 2018
NCT02270203a	LOIS: Long-Term Follow-Up in INSITE/SIFI	103	Dec 2019
NCT02074761a	Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System	250	Aug 2020
NCT03230279a	Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction	84	Sep 2023 (withdrawn)

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Sacroiliac Joint Fusion/Stabilization
SI Joint Fusion
SI Joint Stabilization
Fusion, SI Joint
Stabilization, SI Joint
iFuse Implant System
SI-LOK Sacroiliac Joint Fixation

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

27279
27280