PROPOSED Local Coverage Determination (LCD)

Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ)

DL39810

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Source LCD ID
N/A
Proposed LCD ID
DL39810
Original ICD-9 LCD ID
Not Applicable
Proposed LCD Title
Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ)
Proposed LCD in Comment Period
Source Proposed LCD
Original Effective Date
N/A
Revision Effective Date
N/A
Revision Ending Date
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Retirement Date
ANTICIPATED 11/20/2025
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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Covered Indications

Minimally Invasive (MI) Arthrodesis of the sacroiliac joint (SIJ) WITH placement of a transfixation device is considered medically reasonable and necessary when ALL of the following criteria are met:

  1. Moderate to severe low back pain (LBP) primarily experienced over the anatomical location of the SIJs between the upper level of the iliac crests and the gluteal fold AND

  1. The pain in the SIJ that causes functional impairment and pain must be measured on a pain scale. Pain assessment must be performed and documented at baseline and after each diagnostic procedure using the same pain scale for each assessment AND

  1. LBP duration of at least 6 months with documented failure to respond to noninvasive conservative management (CM) (as tolerated). This CM should include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program, AND

  1. LBP below L5 without radiculopathy, AND

  1. Clinical findings and/or imaging studies do not suggest any other diagnosed or obvious cause of the lumbosacral pain (such as central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, infection, tumor, fracture, pseudoarthrosis, or pain related to spinal instrumentation), AND

  1. At least 3 positive findings with provocative maneuvers: flexion abduction external rotation (FABER), Gaenslen, Thigh Thrust or Posterior Shear, SI Compression, SI Distraction and Yeoman Tests, AND

  1. Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia) AND

  1. At least 75% reduction of pain for the expected duration of the injected anesthetic agent on 2 separate visits, the ability to perform previously painful maneuvers, following an image-guided, contrast-enhanced intra-articular SIJ injection AND

  1. A trial of at least 1 therapeutic intra-articular SIJ injection (i.e., corticosteroid injection that results in a 50% reduction of pain for the expected duration of the injected agent AND

  1. Diagnostic imaging studies that include ALL the following:

    • Imaging (plain radiographs and a computed tomography (CT) or magnetic resonance imaging (MRI)) of the SIJ that excludes the presence of destructive lesions (e.g., tumor, infection), fracture, traumatic SIJ instability, or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion (SIJF)
    • Imaging of the pelvis (anteroposterior (AP) plain radiograph) to rule out concomitant hip pathology
    • 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

MI Arthrodesis of the SIJ WITHOUT placement of a transfixation device is NOT considered medically reasonable and necessary.

Summary of Evidence

The SIJ is a synovial or diarthrosis-amphiarthrosis joint, whose primary function is to transfer weight to and from the lower extremities to the axial skeleton.1 The SIJ has been implicated as a source of chronic LBP in 15% to 30% of patients.2 The SIJ contains both mechanoreceptors and nociceptive receptors such that SIJ pathology leads to pain in the buttocks, lower back, groin or leg. SIJ degeneration commonly occurs, especially after lumbar fusion. The SIJ is particularly enigmatic in its ability to mimic hip and lumbar spine pathology and also to result from the surgical treatment of hip and spine issues.3 Patients with SIJ pain report Oswestry Disability Index (ODI) scores in the 50s and the burden of disease associated with SIJ pain is at least as high as that associated with other musculoskeletal conditions such as hip osteoarthritis, degenerative spondylolisthesis, or spinal stenosis; conditions that are often treated surgically.4 Risk factors for SIJ dysfunction may include abnormal gait, scoliosis, degenerative and inflammatory arthritis, previous lumbar spinal surgery, trauma, and childbirth.5 In addition, the SIJ may be a referred site of pain, including from a degenerative disc at L5-S1, spinal stenosis, or osteoarthritis of the hip.

Diagnosis remains problematic, with no universally accepted reference standard. Current best practice diagnostic techniques start with pain provocation testing. A positive result on 3 or more pain provocation tests, such as Gaenslen’s, FABER, compression, distraction and thigh thrust, are used as criteria for further testing to confirm the SIJ as the primary pain generator. Typically, diagnostic blocks and intraarticular fluoroscopically guided injections are then used for confirmation of SIJ disorder. A standard of ≥75% relief of pain has been suggested as an indication of pain deriving from the SIJ. X-ray, CT or MRI of the SIJ has not proven to be sensitive or specific enough to be used alone but may be helpful when used in conjunction with other diagnostic techniques. Radiographic utility lies more in excluding the presence of other causes of pain that would not be properly addressed by percutaneous SIJF.3,6,7

The mainstay of therapy for disorders of the SIJ has been nonoperative treatment, including activity modification, NSAIDs, physical therapy, radiofrequency neurotomy and SIJ injections (SIJIs). High quality clinical evidence corroborating the benefits of these non-surgical therapeutic options is limited by small patient populations, lack of placebo controls, and failure to utilize validated outcome measures.8 When these modalities fail, the International Society for the Advancement of Spine Surgery (ISASS) recommends SIJ arthrodesis.9 Surgical treatment is indicated for patients with a positive response to an SIJ injection with >75% relief, failure of nonsurgical treatment, and continued or recurrent SIJ pain.

Traditional open SIJF procedures are complex and invasive, involving open exposure of the joint with instrumented fixation and/or bone graft harvesting, and are typically associated with lengthy hospital stays, large blood loss and prolonged recovery times. Outcomes of traditional SIJF procedures were observed to be so poor with a high rate of reported non-union that these procedures were virtually abandoned over the last few decades.10 However, in the case of revision surgery, nonunion, and aberrant anatomy, open arthrodesis should be performed.11

To review literature on devices for SIJF, PubMed® was searched using the Boolean phrase “sacroiliac joint AND (fusion OR arthrodesis)” since 2010. To establish a list of SIJF devices not represented in the literature, searches were performed on the Federal Drug Administration (FDA) 510(k), premarket approval, and De Novo databases, as well as Google and LinkedIn. Literature review yielded 11 FDA-approved devices for MI SIJF. Database query yielded an additional 22 devices for a total of 33 devices. Twenty-one devices used the lateral transiliac approach, 6 posterior allograft approaches, 3 posterolateral approaches, and 3 combined the lateral transiliac and posterolateral approaches. The evidence for the lateral transiliac approach is the most robust.12 This approach is also termed arthrodesis with placement of a transfixation device.

Arthrodesis with Placement of Transfixation Device

More recently, MI techniques with novel implants have been developed that are designed to confer the benefits of permanent SIJ stabilization but with a more reasonable safety profile. To date, most published data describe use of a lateral transfixing approach. While a small number of studies describe use of hollow modular anchor screws, a larger number describe use of triangular titanium implants (TTIs) with a porous surface. These implants serve to minimize rotation and maximize surface area at the SIJ.13

Kube and Muir14 evaluated 1 year clinical results from a cohort of 18 patients with SIJ pain unresponsive to conservative treatment who underwent minimally invasive surgical (MIS) SIJFs. At 12 months, the overall fusion rate was 88%. Back and leg pain improved from 81.7 to 44.1 points on the visual analog scale (VAS) (p<0.001) and from 63.6 to 27.7 points (p<0.001), respectively. Disability scores improved from 61.0 to 40.5 (p<0.009) on the ODI. No major complications were reported.

Similar results were noted by Rainov et al.15 in their retrospective study of 160 patients with painful SIJ dysfunction who underwent unilateral or bilateral SIJF using TTIs. By 12 months, pain decreased from 8.0 to 2.5 (VAS) (p<0.0001) and disability (ODI) from 45.3 to 16.4 (p<0.001).

A prospective multicenter single arm interventional trial looking at 172 subjects with MIS for SIJ dysfunction was conducted by Duhon et al.16 Patients completed VAS and ODI assessments preoperatively, and at 1, 3, 6, and 12 months postoperatively. Patient satisfaction with surgery was also assessed at 6 and 12 months. Mean VAS improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively. Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months. At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again. Follow-up at 24 months demonstrated sustainability of quality-of-life scores using EuroQol-5 Dimension (EQ5D), as well as a decrease from 76.2% at baseline of opioid usage to 55.0% at 24 months (p<0.0001). CT scan at 1 year demonstrated a high rate of bone adherence (97%) to at least 2 implants on both the iliac and sacral sides with modest bone growth across the SIJ.17

Polly et al.18 described 2-year outcomes from a Level 1 multicenter randomized controlled trial (RCT) of MIS vs non-surgical management (NSM) for SIJ dysfunction. One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to MI SIJF with TTIs (SIJF, n=102) or NSM, n=46). SIJ pain score utilizing VAS, disability score utilizing ODI and quality of life EQ5D scores were collected at baseline and at scheduled visits to 24 months. In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<0.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit, respectively, in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10%. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period.

In a long-term (3-year) follow-up, MI trans-iliac SIJF with TTIs continued to be associated with improved pain, disability, and quality of life with relatively high satisfaction rates.19 Subjects included in this Long Term Outcomes Study (LOIS) were enrolled at 12 centers who participated in either INSITE or SIFI. INSITE is a prospective multicenter randomized trial of SIJF vs. NSM whose 2-year results showed high degrees of improvement in pain, disability and quality of life in the surgical group but only modest responses in the non-surgical group. SIFI is a prospective multicenter single-arm clinical trial evaluating the same procedure/device; the follow-up schedule and assessments were nearly identical, and 2-year results were similarly positive.

Study follow-up in LOIS consisted of phone calls postoperatively at years 2.5, 3.5, and 4.5 as well as in-clinic study visits at years 3, 4, and 5. Phone calls were intended to maintain subject contact and assess for adverse events. At in-clinic visits, subjects completed surveys to assess SIJ pain and LBP scores (VAS), ODI, quality of life (EQ5D) time trade-off (TTO) index, and satisfaction. All questionnaires were administered by trained study research coordinators. Of 127 potentially eligible INSITE/SIFI subjects, 103 were enrolled in LOIS. Mean preoperative SIJ pain score was 81.5 and mean preoperative ODI was 56.3. At 3 years, mean SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI decreased to 28.2 (a 28-point improvement from baseline, p<0.0001). In all, 82% of subjects were very satisfied with the procedure at 3 years. EQ5D TTO index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported.

A comparative 6-year retrospective case series by Vanaclocha et al.20 looked at MIS, radiofrequency denervation and CM for SIJ pain. The study was not randomized, and some patients were unable to undergo radiofrequency ablation (RFA) or MIS due to insurance reasons, so there was a pool of patients who had CM only. Out of the 152 patients who had a positive response to SIJ infiltration, 74 continued with CM, 51 underwent SI denervation and 27 underwent SIJF. In the CM group, 63 patients had 1-yr follow-up, and 2-, 3-, 4-, 5-, and 6-yr follow-up was available in 52, 43, 34, 23, and 16 patients, respectively. In the SI denervation group, 47 had 1-yr follow-up and further follow-up (same time points) was available in 41, 33, 23, 6, and 2 patients. In the SIJF group, 27 patients had 1-year follow-up and further follow-up was available in 24, 20, 15, 6, and 1 patient. Pain relief was seen at 1 month after CM, SI denervation, and SIJF. However, pain returned to near baseline levels in the CM and SI denervation groups with further follow-up. In contrast, SIJ pain remained low postoperatively in the SIJF group. At 6 months and beyond, the mean difference in pain improvement between the CM and SIJF groups was approximately 6 points (repeated measures analysis of variance, P<0.001), and the difference between the SI denervation and SIJF groups was approximately 4.5 points (P<0.001). Similar findings were seen with ODI, which showed improvement after SI infiltration but return of high scores within 6 months. ODI scores improved substantially after SIJF but returned to baseline levels in the CM and SI denervation groups. Mean ODI differences beyond 6 months were as follows: SIJF vs CM, 24 points (P<0.001); SIJF vs SI denervation, 17 points (P<0.001). No patient in the CM and SI denervation groups had an improvement in ODI of at least 15 points at year 4; in contrast, all SIJF patients showed at least a 15-point improvement at year 4 (P<0.001).

There are other approaches in addition to the lateral approach that still result in transfixation rather than distraction. Raikar21 reported on a small series of 19 patients aged 44-84 years, with a median of 58 years, underwent SIJF using this technique. The follow-up is between 7 and 30 months, with a median of 12 months. Eighteen patients had excellent pain relief. There was no complication from the procedure, and the blood loss was minimal. All 8 patients who had follow-up radiographs showed solid fusion. With the posterior oblique approach described in this paper, the screw entry point is on the upper outer surface of the iliac crest. This negates the need to dissect through the gluteal fascia to reach the ileum. This decreases the risk of injury to the superior gluteal neurovascular structures and the cuneal nerves. It also makes it a relatively bloodless procedure, which can be performed in an outpatient setting. This contrasts with the lateral approach in which the average blood loss has been reported to be between 31 and 42.8 cc, and with an average length of stay between 0.8 and 1.9 days.15,16 The posterior oblique approach also allows the surgical trajectory to remain within the ileum and sacrum, resulting in minimal soft tissue manipulation. In the straight posterior approach in which a bone plug is inserted into the joint, there is distraction of the joint.19 This contrasts with the posterior oblique approach, in which the screws decrease movement in the joint by bringing the joint surfaces together. Theoretically, bringing the joint surfaces together should be more effective in decreasing pain because there is less room for movement within the joint. In addition, in the posterior approach, because the joint space is expanded, the bone graft may move, if fusion does not occur.

Arthrodesis without Placement of Transfixation Device

The aforementioned transfixation procedure is typically performed from a lateral approach. The procedures that are non-transfixation approaches are usually performed from a dorsal (posterior) approach though at times are combined into dorsa-lateral approach. Rather than transfixing the SIJ, these procedures utilize distraction arthrodesis.

MI posterior SIJF was first introduced as a procedure in 2008 for the treatment of SIJ dysfunction. This procedure attempts to stabilize the SIJs by fusing the sacrum to the ilium with allograft material, limiting movement of the joint.22 The posterior (dorsal) SIJF procedure is distinct from lateral trans-iliac MIS SIJF using transfixing devices in several ways9:

  • The surgeon’s work effort is distinct with the dorsal procedure requiring less surgical dissection, and the procedure generally takes less time.
  • Initial stabilization is not achieved via transfixation with a laterally placed device, but rather by tensioning of the ligaments supporting the SIJ via placement of a bone graft or allograft implant.
  • Long-term stabilization or fusion is achieved via distraction arthrodesis rather than by integration of the surrounding bone of the ilium and sacrum.
  • Distraction arthrodesis of the SIJ consists of placement of an implant or bone allograft into the ligamentous portion of the SIJ, this places the supporting ligaments under tension.
  • Bone graft and/or recombinant human bone morphogenetic protein are utilized to achieve bone fusion.

Placement of SIJF allograft implants via a posterior approach is intended to be less invasive and avoid risks associated with encountering the neurovascular bundle.23 Examples of posterior SIJ stabilization devices are CornerLoc™ (Foundation Fusion Solutions, LLC.), TransFasten (Captiva Spine®), and LinQ™ (PainTEQ.

Based on the FDA's criteria for determining whether a structural allograft averts regulatory oversight and classification as a drug/device/biologic, mineralized bone allografts were judged to meet the Agency's definitional descriptions for minimal manipulation and homologous use when complying with the American Association of Tissue Banks’ (AATB) accredited guidelines for bone allograft harvesting, processing, storing and transplanting. Thus, these products do not require FDA medical device clearance. Radiographic fusion rates achieved with mineralized bone allografts were uniformly high (>85%) across 3 published systematic reviews. Little variation was found in the fusion rates irrespective of anatomical location, allograft geometry, dimensions or indication, and in most cases, the rates were similar to those for autologous bone alone.24

This posterior fusion approach aims to reduce neurological complications by avoiding the sacral foramen, passes through and manipulating less soft tissue, avoiding nervous and arterial structures, and decreasing post-op recovery time. Unlike the lateral approach which typically requires patients to undergo general anesthesia, the posterior approach can be performed under conscious sedation with local anesthetic and is typically an outpatient day surgery procedure.25

Initial research of this method was first conducted on cadavers. Six cadaveric SIJ specimens were tested under intact, unilateral fixation, and bilateral fixation conditions. The total range of motion (ROM) of the SIJ in flexion-extension, lateral bending, and axial rotation were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between +/- 7.5 Nm applied moment loads. The centers of the instantaneous axis of rotation (cIAR) of the SIJ were evaluated during flexion-extension loading. A correlation analysis was performed between the ROM reduction in flexion-extension upon implantation and shift of the cIAR to the graft implantation site. RESULTS: Unilateral and bilateral fixations generated SIJ ROM reductions in flexion-extension, lateral bending, and axial rotation motions. Fixation shifted the cIAR to the graft implantation site. Reduction in the total ROM had a moderate correlation with the shift of the cIAR. The conclusion was that the novel posterior approach presented a multifaceted mechanism for stabilizing the joint: first, by the reduction of the total ROM in all planes of motion; second, by shifting the centers of the cIAR towards the implant's location in the predominant plane of motion, ensuring little to no motion at the implantation site, thus promoting fusion in this region.26 During flexion–extension, the posterior approach is equivalent to the lateral approach, while producing superior stabilization during lateral bend and axial rotation.27

Deer et al.25 conducted a multicenter retrospective observational study of patients with refractory SIJ pain treated by interventional pain physicians at 1 of the 8 different pain management centers. A total of 111 patients were included in the study and underwent posterior SIJF via the LinQ™ SIJF procedure for refractory SIJ-related pain following the use of spinal cord stimulation (SCS), interspinous spacer (ISS), intrathecal drug delivery (IDDS), and/or minimally invasive lumbar decompression (MILD). Overall, the mean patient reported pain relief following posterior SIJF was 67.6%. In patients with a history of failed back surgery syndrome, the mean patient reported pain relief was 76.5%. In this retrospective case series of patients with continued intolerable pain following SCS, ISS, IDDS, or MILD, the posterior SIJF device provided significant pain relief in a salvage manner.25

Caheuque et al.28 conducted a retrospective cohort study that analyzed data from 45 patients who underwent SIJF. Included patients were >/=50 years old, nonresponsive to conservative treatment. Subjects were divided into 2 cohorts based on the SIJF technique. Primary outcomes were pain relief, measured by VAS, and functional improvement, determined by the ODI; both were recorded and assessed at baseline, postoperative, and the change from pre- to postoperative. Additionally, data regarding patient demographics, previous lumbar fusion, operative time, and duration of hospital stay were collected and analyzed. Baseline demographic and clinical variables exhibited no significant differences in distribution between groups. The posterior oblique cohort demonstrated a substantial reduction in operative time (over 50%) and duration of hospital stay compared to lateral cohort. Pain relief (postoperative VAS: lateral 3.5+/-1.7 vs. posterior oblique 2.4+/-1.5 [p=0.02]) and functional improvement (postoperative ODI: lateral 29.6+/-7.3 vs. posterior oblique 21+/-5.7 [p</=0.001]) were significantly better in the posterior oblique group. Pre- to postoperative improvement analysis indicated greater reduction in pain (VAS: lateral -4.4+/-1.9 vs. posterior oblique -6.1+/-1.5 [p=0.002]) in the posterior oblique group. Their conclusion was that compared to the lateral technique group, patients undergoing MI SIJF through the posterior oblique technique experienced greater pain relief and demonstrated a trend toward better functional improvement, with shorter operative times and duration of hospital stay. They suggested that the posterior oblique technique may be more efficient and beneficial to manage patients suffering from chronic SIJ pain through joint fusion and suggested further studies.

Sayed et al.29 conducted a multicenter 12-month retrospective analysis of the long-term efficacy and safety of the device, with sub-analysis of patients with prior lumbar fusions. Patients with sacroiliitis refractory to conservative care with short-term benefit from diagnostic local anesthetic SIJIs receiving MI posterior approach SIJF with allograft were included from different centers including both academic and private practice. Numeric rating scale (NRS) scores at baseline (pre-procedural) and most recent follow-up were reviewed across 3 institutions. Of 110 patients who received MI SIJF, 50 patients had sufficient data for evaluation of outcomes at least 12 months post-implant. The average time out from implant at follow-up was 612.2 days for all unique patients. The average NRS was 6.98 pre-fusion and 3.06 at last follow-up. Twenty-four patients had prior lumbar surgery of which 17 had prior lumbar fusions. Average NRS for this subset was 6.85 at baseline and 2.86 at last follow-up with an average follow-up of 613.2 days out from implant. No major adverse events or complications were associated with any of the 50 implants. This study concluded that the evidence suggested that MI posterior SIJF is a viable approach for medically refractory sacroiliitis management with long-term efficacy and safety. However, further prospective studies are needed to fully evaluate this technique.

Calodney et al.30 is presently conducting a prospective safety and efficacy trial of this approach in the SECURE trial. This is a multicenter, prospective, single arm study which was performed after patient identification and treatment with the novel posterior fusion, single point transfixation system and followed for 24 months. Target enrollment is 100 patients. Interim results on the first 69 consecutive patients at 6 months has been presented. Primary endpoint at 6-month analysis was pain intensity reduction by VAS and functional improvement by ODI. Adverse events were assessed for safety analysis. RESULTS: In total, 69 patients were identified for this analysis. At 6 months, a mean improvement of 34.9 was identified by a reduction in VAS and functional improvement was demonstrated by a mean reduction in ODI of 17.7. There were 3 adverse events, all unrelated to the device. The conclusion by Calodney was that the posterior single point transfixation is safe and efficacious for the treatment of SIJ dysfunction with statistical improvements in pain and function. The results from the 12-month follow-up have yet to be published.

Analysis of Evidence (Rationale for Determination)

There is moderate quality evidence that MI arthrodesis with placement of transfixation device for SIJF is an acceptable option for patients with chronic SIJ dysfunction due to degenerative sacroiliitis and SIJ disruptions unresponsive to non-surgical treatments. Implants are consistently associated with improved pain and disability from baseline without substantial safety concerns. This improvement appears to be sustained in the long term. Because diagnostic techniques for SIJ dysfunction can be unreliable, this may be a potential confounding factor in analysis of treatment protocols. Because of these issues, the North American Spine Society (NASS) reports there is insufficient evidence to make a recommendation for or against SIJF compared with medical treatment for the treatment of LBP due to SIJ dysfunction.

The level of support in the clinical literature for the non-transfixation procedure is far lower than for the transfixation procedure.31 There were no systematic reviews, with or without meta-analysis, or RCTs found in the literature search. The evidence that exists is of low quality and is entirely industry supported. The longest observation period published has been for 6 months. This procedure is not recommended by the ISASS, while it does state that transiliac procedures for SIJF have become a recognized safe, predictable, and preferred surgical method for the management of intractable, debilitating primary or secondary SIJ pain disorders.31 Query of other payer LCDs reveals that for those that have an LCD on MIS of SIJ, MI posterior dorsal approach to access the SIJ, including use of implants other than those which are placed across the joint (i.e., transfixing) to promote fusion (e.g., allograft , nonmetallic implants), is considered experimental, investigation, or unproven. Based on all these factors, the MIS approach that does not transfix the SIJ is not considered reasonable and necessary.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
Not Applicable N/A
Associated Information
N/A
Sources of Information

Cigna: Lumbar Fusion for Spinal Instability and Degenerative Disc Conditions, Including Sacroiliac Fusion (cigna.com)

United Healthcare: Sacroiliac Joint Interventions

BCBS of Massachusetts: Diagnosis and Treatment of Sacroiliac Joint Pain

BCBS of Louisiana: Sacroiliac Joint Fusion (Percutaneous/Minimally Invasive Techniques)

Sacroiliac Joint Injections and Procedures L39402 LCD

Reviewed but not cited:

Blue Cross Blue Shield Association. Diagnosis and treatment of sacroiliac joint pain: Evidence summary. Evidence Street®. June 2023:1-55.

Buchanan P, Lee D, Comer A, et al. Best practices for postoperative management of posterior sacroiliac joint fusion. J Pain Res. 2022;15:1149-1162.

Sayed D, Khatri N, Rupp A, et al. Salvage of failed lateral sacroiliac joint fusion with a novel posterior sacroiliac fusion device: Diagnostic approach, surgical technique, and multicenter case series. J Pain Res. 2022;15:1411-1420.

Bibliography
  1. Aranke M, McCrudy G, Rooney K, et al. Minimally invasive and conservative interventions for the treatment of sacroiliac joint pain: A review of recent literature. Orthop Rev. 2022;14(3):1-11.
  2. Ledonio CG, Polly DW, Jr., Swiontkowski MF. Minimally invasive versus open sacroiliac joint fusion: Are they similarly safe and effective? Clin Orthop Relat Res. 2014;472(6):1831-1838.
  3. Buchanan P, Vodapally S, Lee DW, et al. Successful diagnosis of sacroiliac joint dysfunction. J Pain Res. 2021;14:3135-3143.
  4. Polly DW, Cher DJ, Wine KD, et al. Randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants vs nonsurgical management for sacroiliac joint dysfunction: 12-Month outcomes. 2015;77(5):674-690; discussion 690-691.
  5. Beck CE, Jacobson S, Thomasson E. A retrospective outcomes study of 20 sacroiliac joint fusion patients. 2015;7(4):e260.
  6. Chuang CW, Hung SK, Pan PT, Kao MC. Diagnosis and interventional pain management options for sacroiliac joint pain. Tzu Chi Med J. 2019;31(4):207-210.
  7. Falowski S, Sayed D, Pope J, et al. A review and algorithm in the diagnosis and treatment of sacroiliac joint pain. J Pain Res. 2020;13:3337-3348.
  8. Dengler J, Kools D, Pflugmacher R, et al. Randomized trial of sacroiliac joint arthrodesis compared with conservative management for chronic low back pain attributed to the sacroiliac joint. J Bone Joint Surg Am. 2019;101(5):400-411.
  9. Lorio MP. ISASS policy 2016 update - Minimally invasive sacroiliac joint fusion. Int J Spine Surg. 2016;10(26):1-16.
  10. Duhon BS, Cher DJ, Wine KD, et al. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: A prospective study. Med Devices (Auckl). 2013;6:219-229.
  11. Schmidt GL, Bhandutia AK, Altman DT. Management of sacroiliac joint pain. J Am Acad Orthop Surg. 2018;26(17):610-616.
  12. Himstead AS, Brown NJ, Shahrestani S, et al. Trends in diagnosis and treatment of sacroiliac joint pathology over the past 10 years: Review of scientific evidence for new devices for sacroiliac joint fusion. 2021;13(6):e15415.
  13. Smith AG, Capobianco R, Cher D, et al. Open versus minimally invasive sacroiliac joint fusion: A multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res. 2013;7(1):14.
  14. Kube RA, Muir JM. Sacroiliac joint fusion: One year clinical and radiographic results following minimally invasive sacroiliac joint fusion surgery. Open Orthop J. 2016;10:679-689.
  15. Rainov NG, Schneiderhan R, Heidecke V. Triangular titanium implants for sacroiliac joint fusion. Eur Spine J. 2019;28(4):727-734.
  16. Duhon BS, Cher DJ, Wine KD, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: A prospective study. Global Spine J. 2016;6(3):257-269.
  17. Duhon BS, Bitan F, Lockstadt H, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up from a prospective multicenter trial. Int J Spine Surg. 2016;10:13.
  18. Polly DW, Swofford J, Whang PG, et al. Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction. Int J Spine Surg. 2016;10:28.
  19. Darr E, Meyer SC, Whang PG, et al. Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2018;11:113-121.
  20. Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-Year comparative case series. 2018;82(1):48-55.
  21. Raikar SV, Nilles-Melchert T, Patil AA, et al. Posterior oblique approach for sacroiliac joint fusion. 2023;15(1):e33502.
  22. Wise CL, Dall BE. Minimally invasive sacroiliac arthrodesis: Outcomes of a new technique. J Spinal Disord Tech. 2008;21(8):579-584.
  23. Lee DW, Patterson DG, Sayed D. Review of current evidence for minimally invasive posterior sacroiliac joint fusion. Int J Spine Surg. 2021;15(3):514-524.
  24. Hubbell PJ, Roth B, Block JE. Comparative evaluation of mineralized bone allografts for spinal fusion surgery. J Funct Biomater. 2023;14(7).
  25. Deer TR, Rupp A, Budwany R, et al. Pain relief salvage with a novel minimally invasive posterior sacroiliac joint fusion device in patients with previously implanted pain devices and therapies. J Pain Res. 2021;14:2709-2715.
  26. Sayed D, Amirdelfan K, Naidu RK, Raji OR, Falowski S. A cadaver-based biomechanical evaluation of a novel posterior approach to sacroiliac joint fusion: Analysis of the fixation and center of the instantaneous axis of rotation. Med Devices (Auckl). 2021;14:435-444.
  27. Sayed D, Amirdelfan K, Hunter C, et al. Posterior intra-articular fixation stabilizes both primary and secondary sacroiliac joints: A cadaveric study and comparison to lateral trans-articular fixation literature. J Orthop Surg Res. 2023;18(1):406.
  28. Cahueque M, Grajeda J, Ardebol J, Azmitia E. Posterior oblique technique for sacroiliac joint fusion leads to greater pain relief and similar improvement in function compared to the lateral technique: A retrospective, comparative study. N Am Spine Soc J. 2023;15:100259.
  29. Sayed D, Balter K, Pyles S, et a;. A multicenter retrospective analysis of the long-term efficacy and safety of a novel posterior sacroiliac fusion device. J Pain Res. 2021;14:3251-3258.
  30. Calodney AK, Azeem N, Buchanan P, et al. Six month interim outcomes from SECURE: A single arm, multicenter, prospective, clinical study on a novel minimally invasive posterior sacroiliac fusion device. Expert Rev Med Devices. 2022;19(5):451-461.
  31. Lorio M, Kube R, Araghi A. International society for the advancement of spine surgery policy 2020 update - Minimally invasive surgical sacroiliac joint fusion (for chronic sacroiliac joint pain): Coverage indications, limitations, and medical necessity. Int J Spine Surg. 2020;14(6):860-895.
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Sources of Information

Cigna: Lumbar Fusion for Spinal Instability and Degenerative Disc Conditions, Including Sacroiliac Fusion (cigna.com)

United Healthcare: Sacroiliac Joint Interventions

BCBS of Massachusetts: Diagnosis and Treatment of Sacroiliac Joint Pain

BCBS of Louisiana: Sacroiliac Joint Fusion (Percutaneous/Minimally Invasive Techniques)

Sacroiliac Joint Injections and Procedures L39402 LCD

Reviewed but not cited:

Blue Cross Blue Shield Association. Diagnosis and treatment of sacroiliac joint pain: Evidence summary. Evidence Street®. June 2023:1-55.

Buchanan P, Lee D, Comer A, et al. Best practices for postoperative management of posterior sacroiliac joint fusion. J Pain Res. 2022;15:1149-1162.

Sayed D, Khatri N, Rupp A, et al. Salvage of failed lateral sacroiliac joint fusion with a novel posterior sacroiliac fusion device: Diagnostic approach, surgical technique, and multicenter case series. J Pain Res. 2022;15:1411-1420.

Bibliography
  1. Aranke M, McCrudy G, Rooney K, et al. Minimally invasive and conservative interventions for the treatment of sacroiliac joint pain: A review of recent literature. Orthop Rev. 2022;14(3):1-11.
  2. Ledonio CG, Polly DW, Jr., Swiontkowski MF. Minimally invasive versus open sacroiliac joint fusion: Are they similarly safe and effective? Clin Orthop Relat Res. 2014;472(6):1831-1838.
  3. Buchanan P, Vodapally S, Lee DW, et al. Successful diagnosis of sacroiliac joint dysfunction. J Pain Res. 2021;14:3135-3143.
  4. Polly DW, Cher DJ, Wine KD, et al. Randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants vs nonsurgical management for sacroiliac joint dysfunction: 12-Month outcomes. 2015;77(5):674-690; discussion 690-691.
  5. Beck CE, Jacobson S, Thomasson E. A retrospective outcomes study of 20 sacroiliac joint fusion patients. 2015;7(4):e260.
  6. Chuang CW, Hung SK, Pan PT, Kao MC. Diagnosis and interventional pain management options for sacroiliac joint pain. Tzu Chi Med J. 2019;31(4):207-210.
  7. Falowski S, Sayed D, Pope J, et al. A review and algorithm in the diagnosis and treatment of sacroiliac joint pain. J Pain Res. 2020;13:3337-3348.
  8. Dengler J, Kools D, Pflugmacher R, et al. Randomized trial of sacroiliac joint arthrodesis compared with conservative management for chronic low back pain attributed to the sacroiliac joint. J Bone Joint Surg Am. 2019;101(5):400-411.
  9. Lorio MP. ISASS policy 2016 update - Minimally invasive sacroiliac joint fusion. Int J Spine Surg. 2016;10(26):1-16.
  10. Duhon BS, Cher DJ, Wine KD, et al. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: A prospective study. Med Devices (Auckl). 2013;6:219-229.
  11. Schmidt GL, Bhandutia AK, Altman DT. Management of sacroiliac joint pain. J Am Acad Orthop Surg. 2018;26(17):610-616.
  12. Himstead AS, Brown NJ, Shahrestani S, et al. Trends in diagnosis and treatment of sacroiliac joint pathology over the past 10 years: Review of scientific evidence for new devices for sacroiliac joint fusion. 2021;13(6):e15415.
  13. Smith AG, Capobianco R, Cher D, et al. Open versus minimally invasive sacroiliac joint fusion: A multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res. 2013;7(1):14.
  14. Kube RA, Muir JM. Sacroiliac joint fusion: One year clinical and radiographic results following minimally invasive sacroiliac joint fusion surgery. Open Orthop J. 2016;10:679-689.
  15. Rainov NG, Schneiderhan R, Heidecke V. Triangular titanium implants for sacroiliac joint fusion. Eur Spine J. 2019;28(4):727-734.
  16. Duhon BS, Cher DJ, Wine KD, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: A prospective study. Global Spine J. 2016;6(3):257-269.
  17. Duhon BS, Bitan F, Lockstadt H, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up from a prospective multicenter trial. Int J Spine Surg. 2016;10:13.
  18. Polly DW, Swofford J, Whang PG, et al. Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction. Int J Spine Surg. 2016;10:28.
  19. Darr E, Meyer SC, Whang PG, et al. Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2018;11:113-121.
  20. Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-Year comparative case series. 2018;82(1):48-55.
  21. Raikar SV, Nilles-Melchert T, Patil AA, et al. Posterior oblique approach for sacroiliac joint fusion. 2023;15(1):e33502.
  22. Wise CL, Dall BE. Minimally invasive sacroiliac arthrodesis: Outcomes of a new technique. J Spinal Disord Tech. 2008;21(8):579-584.
  23. Lee DW, Patterson DG, Sayed D. Review of current evidence for minimally invasive posterior sacroiliac joint fusion. Int J Spine Surg. 2021;15(3):514-524.
  24. Hubbell PJ, Roth B, Block JE. Comparative evaluation of mineralized bone allografts for spinal fusion surgery. J Funct Biomater. 2023;14(7).
  25. Deer TR, Rupp A, Budwany R, et al. Pain relief salvage with a novel minimally invasive posterior sacroiliac joint fusion device in patients with previously implanted pain devices and therapies. J Pain Res. 2021;14:2709-2715.
  26. Sayed D, Amirdelfan K, Naidu RK, Raji OR, Falowski S. A cadaver-based biomechanical evaluation of a novel posterior approach to sacroiliac joint fusion: Analysis of the fixation and center of the instantaneous axis of rotation. Med Devices (Auckl). 2021;14:435-444.
  27. Sayed D, Amirdelfan K, Hunter C, et al. Posterior intra-articular fixation stabilizes both primary and secondary sacroiliac joints: A cadaveric study and comparison to lateral trans-articular fixation literature. J Orthop Surg Res. 2023;18(1):406.
  28. Cahueque M, Grajeda J, Ardebol J, Azmitia E. Posterior oblique technique for sacroiliac joint fusion leads to greater pain relief and similar improvement in function compared to the lateral technique: A retrospective, comparative study. N Am Spine Soc J. 2023;15:100259.
  29. Sayed D, Balter K, Pyles S, et a;. A multicenter retrospective analysis of the long-term efficacy and safety of a novel posterior sacroiliac fusion device. J Pain Res. 2021;14:3251-3258.
  30. Calodney AK, Azeem N, Buchanan P, et al. Six month interim outcomes from SECURE: A single arm, multicenter, prospective, clinical study on a novel minimally invasive posterior sacroiliac fusion device. Expert Rev Med Devices. 2022;19(5):451-461.
  31. Lorio M, Kube R, Araghi A. International society for the advancement of spine surgery policy 2020 update - Minimally invasive surgical sacroiliac joint fusion (for chronic sacroiliac joint pain): Coverage indications, limitations, and medical necessity. Int J Spine Surg. 2020;14(6):860-895.

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Keywords

  • MIS
  • SIJ
  • SIJF
  • transfixation
  • non-transfixation

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