Coverage Policy Manual
Policy #: 2013005
Category: Surgery
Initiated: January 2013
Last Review: January 2019
  Sacroiliac Joint Fusion, Minimally Invasive

Description:
Treatment options for sacroiliac (SI) joint pain include physical therapy, oral pain medications, SI joint injections, radiofrequency ablation and open surgical SI joint fusion. A minimally invasive surgical technique has been proposed using the iFuse Implant System®.
 
The iFuse Implant System® (SI-Bone, Inc.) consists of titanium implants and associated surgical instruments. The surgical procedure involves a 2-3 cm incision where a series of triangular-shaped titanium implants are placed across the SI joint.
 
Regulatory Status
SI-Bone, Inc. originally received FDA 510K marketing clearance for the iFuse system in November 2008 for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac join disruptions and sacroiliitis. In March 2011, the FDA removed “fracture” from the intended use and gave marketing clearance for the iFuse system for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis (FDA, 2011).
 
Other percutaneous or minimally invasive fixation/fusion devices that have received marketing clearance by FDA include the SI-FIX Sacroiliac Joint Fusion System (Medtronic), the SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies), Silex™ Sacroiliac Joint Fusion System (X-Spine Systems) and the SI-LOK® Sacroiliac Joint Fixation System (Globus Medical).
 
Coding
Effective in 2015, there is a CPT category I code for percutaneous or minimally invasive stabilization:
 
27279: Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device.
 
Effective Prior to 2015
Effective July 1, 2013, there is a CPT category III code for percutaneous or minimally invasive stabilization:
 
0334T: Sacroiliac joint stabilization for arthrodesis, percutaneous or minimally invasive (indirect visualization), includes obtaining and applying autograft or allograft (structural or morselized), when performed, includes image guidance when performed (e.g., CT or fluoroscopic).
  

Policy/
Coverage:
Minimally invasive sacroiliac joint fusion using the iFuse Implant System® or other devices does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, minimally invasive sacroiliac joint fusion using the iFuse Implant System® or other devices is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
Literature Review
A literature search was conducted using the MEDLINE database and the clinicaltrials.gov website. The literature involving the study of the iFuse Implant System consists of small retrospective case series. The following is a summary of the identified literature.
 
Wise  and colleagues published results of a prospective study enrolling thirteen patients with sacroiliac pain (Wise, 2008). All thirteen patients underwent minimally invasive sacroiliac arthrodesis.  Six patients had bilateral fusions for a total of 19 joints fused. A 6 month CT scan showed an overall fusion rate of 89%. Low back pain, leg pain and dyspareunia scores on a visual analog scale (0-10) improved an average of 4.9, 2.4 and 2,6, respectively.
 
In 2012, Sachs and Capobianco reported results of a consecutive case series study of 11 patients treated with the iFuse Implant System® by a single surgeon (Sachs, 2012). Average pain scores decreased from 7.9 at baseline to 2.3 at the 12 month follow-up resulting in a statistically significant (p=0.000) improvement. Both authors were noted to have an affiliation with SI-Bone Inc.
 
The largest study identified was a retrospective study of 50 consecutive patients treated by a single surgeon with minimally invasive sacroiliac joint fusion (Rudolf, 2012). Medical records were reviewed for peri-operative characteristics, complications, pain, quality of life measures and satisfaction with surgery. All patients were contacted at 24 months post surgery to assess pain, satisfaction with surgery and work status. Ten peri-operative complications were reported including three patients with subcuticular skin closures that developed cellulitis and two patients had implant penetration into the sacral neural foramen. A non-displaced fracture was reported in one patient at the edge of the ilium adjacent to the sciatic notch.  The fracture was reported to have healed without intervention.
 
Ongoing Clinical Trials
This device is currently being studied in the following clinical trials:
 
NCT01640353- Sacroiliac Joint Fusion with iFuse Implant System (SIFI). This study is a phase 4 observational study to assess the use of the iFuse Implant System to treat degenerative sacroiliitis and sacroiliac disruption. The estimated completion date is September 2014.
 
NCT01681004-Investigation of Sacroiliac Fusion Treatment (INSITE). A Phase 4 study to compare outcomes in patients undergoing joint fusion using the iFuse Implant System® versus specific, targeted non-surgical treatment. The study is currently recruiting patients and has an estimated completion date of November 2014.
 
NCT 01741025-iFuse Implant System Minimally Invasive Arthrodesis (iMIA).  This study is a multicenter, randomized controlled trial comparing the safety and efficacy of the iFuse for patients with chronic disabling sacroiliac joint pain. This study is scheduled to begin enrollment in March 2013.
 
Regulatory Status
SI-Bone, Inc. originally received FDA 510K marketing clearance for the iFuse system in November 2008 for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac join disruptions and sacroiliitis. In March 2011, the FDA removed “fracture” from the intended use and gave marketing clearance for the iFuse system for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis (FDA, 2011).
 
 
2014 Update
A literature conducted through June 2014 using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.
 
A multicenter retrospective comparison of open versus minimally invasive sacroiliac joint fusion in 263 patients was identified (Smith, 2013). Because all patients received fusion, this trial does not offer evidence on the comparative effectiveness of sacroiliac fusion versus alternative treatment approaches. This study had a pragmatic design that included 7 participating sites; 3 surgeons had performed open sacroiliac joint surgery (n=149), and 4 had performed minimally invasive fusion with the iFuse Implant system (n=114). Patients who underwent minimally invasive fusion were an average of 10 years older and were more likely to have had prior lumbar fusion (47.4% vs 23.5%). Perioperatively, they had lower estimated blood loss (33 vs 288 mL), operating time (70 vs 163 min), and length of hospitalization (1.3 vs 5.1 days). At 12 months postsurgery, and after matching for age, gender, and history of prior lumbar fusion, pain scores were an average of 3 (of 10) points lower in the minimally invasive group (95% confidence interval, 2.1 to 4.0; p<0.001). Implant repositioning was performed in 3.5% of patients in the minimally invasive group, while 44% of patients in the open surgical group underwent removal of spinal implants for pain. (Note: A 2012 survey by the International Society for the Advancement of Spinal Surgery found that nearly 90% of surgeons who replied to the survey used a minimally invasive technique to perform sacroiliac joint fusion (International Society for the Advancement of Spinal Surgery, 2013).
 
In 2012, Rudolf reported a retrospective analysis of his first 50 consecutive patients treated with the iFuse Implant System (Rudolf, 2012). There were 10 perioperative complications, including implant penetration into the sacral neural foramen (2 patients) and compression of the L5 nerve (1 patient); these resolved with surgical retraction of the implant. At a minimum of 24 months’ follow-up (mean, 40 months), the treating surgeon was able to contact 45 patients. The mean pain score was 2, and 82% of patients had attained the minimum clinically important difference (MCID, defined as ≥2 of 10).
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The literature on arthrodesis (open or minimally invasive) for sacroiliac joint pain includes 1 RCT on minimally invasive fusion, 1 cohort study comparing open and minimally invasive sacroiliac fusion, and a number of case series.
 
In 2015, Whang and colleagues reported an industry-sponsored non-blinded RCT (NCT01681004) of the iFuse Implant System in 148 patients (Whang, 2015). Inclusion in the study was based on the determination of the sacroiliac joint as a pain generator from a combination of a history of sacroiliac joint-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in sacroiliac point pain after image-guided local anesthetic injection into the joint. The duration of pain prior to enrollment averaged 6.4 years (range, 0.47 to 40.7 years). Prior treatments in the control group included physical therapy (78.3% of subjects), intra-articular steroid injections (91.3%), and RFA of the sacroiliac nerve roots (8.7%).
 
Patients were assigned in a 2:1 ratio to minimally invasive sacroiliac joint fusion (n=102) or to nonsurgical management (n=46). Non-surgical management included a step-wise progression, depending on individual patient needs, of pain medications, physical therapy (98% of patients), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). The primary outcome measure was 6-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in sacroiliac joint pain in the absence of severe device-related or neurologic adverse events or surgical revision. Missing values were considered to be treatment failures, and the study was considered to meet its endpoint if there was a posterior probability for superiority of fusion of at least 0.975 by Bayesian analysis. Patients in the control arm could cross-over 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 Oswestry Disability Index (ODI) scores averaging 61.9.
 
At 6 months, success rates were 23.9% in the control group versus 81.4% in the surgical group (posterior probability of superiority > 0.999). A clinically important (≥15 point) improvement in the ODI was found in 27.3% of controls compared with 75.0% of fusion patients. Measures of quality of life (SF-36, EQ-5D) also improved to a greater extent in the surgery group. Opioid use remained high in both groups (70.5% for non-surgical controls and 58.0% for fusion patients (p=0.082). Although these results are generally positive, there is a high potential for bias in this nonblinded study with subjective outcome measures. Aside from non-blinding, the study was of high methodologic quality. Follow-up of all patients will continue through 24 months.
 
The International Society for the Advancement of Spine Surgery (ISASS) published a policy statement on minimally invasive sacroiliac joint fusion in 2014.34 ISASS states that patients who meet all of the following criteria may be eligible for minimally invasive sacroiliac joint fusion: significant sacroiliac joint pain or significant limitations in activities of daily living; pain confirmed on physical provocative examination maneuvers that stress the joint; confirmation of the sacroiliac joint as a pain generator with at least 75% acute decrease in pain immediately following fluoroscopically guided diagnostic joint block using local anesthetic; failure to respond to at least 6 months of non-surgical treatment; and additional or alternative diagnoses have been clearly considered, investigated and ruled out.
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Randomized Controlled Trials
In 2015, Whang and colleagues reported an industry-sponsored non-blinded RCT of the iFuse Implant System in 148 patients (Whang, 2015). Twelve-month follow-up to this RCT was reported by Polly and colleagues (Polly, 2015). However, by 12 months, almost all patients in the control group had crossed over to SIJ fusion. Two-year follow-up of this trial was reported by Polly and colleagues (Polly, 2016).  This last publication will be discussed in the case series section of this report. 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. 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, steroid SIJ infections (86%), and RFA (16%).
 
Patients were assigned 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 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).
 
At 6 months, success rates were 23.9% in the control group versus 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 QOL (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 to 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). Although these results generally favored fusion and had high methodologic quality, the trial had a high potential for bias (nonblinded study, subjective outcome measures).
 
In 2016, Sturesson and colleagues reported another industry-sponsored nonblinded RCT of the iFuse Implant System in 103 patients (Sturesson, 2016). Selection criteria were similar to those of the Whang trial, including at least 50% pain reduction on SIJ block. Mean pain duration was 4.5 years. Thirty-three percent 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.
 
Of 109 randomized subjects, 6 withdrew before treatment. All patient assigned to iFuse underwent the procedure, and follow-up at 6 months was in 49 of 51 patients in the control group and in all 52 patients in the iFuse group. 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). QOL outcomes showed a greater improvement in the iFuse group than in the control group. Changes in pain medication use are not reported. Although these results favored fusion, with magnitudes of effect in a range similar to the Whang RCT, this trial was also not blinded and lacked a sham control. Outcomes were only assessed to 6 months.
 
Subsection Summary: Randomized Controlled Trials
Two fair quality RCTs have reported outcome to 6 months, after which crossover was allowed and comparisons between groups are no longer possible. Both studies reported significantly greater improvements in VAS pain scores and ODI scores in SIJ fusion patients than in control groups. Studies were nonblinded without a placebo control. 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. The change in opioid use in surgical patients was less than would be expected from a procedure that reduced pain by the magnitude shown in the study and did not differ statistically significantly from the control group.
 
Case Series with Good Reported Follow-Up Rates
Case series with good follow-up rates are more likely to provide valid estimates of outcomes. Series with good follow-up rates (>80%) are reported in this section
 
In 2012, Rudolf retrospectively analyzed his first 50 consecutive patients treated with the iFuse Implant System (Rudolf, 2012). There were 10 perioperative complications, including implant penetration into the sacral neural foramen (2 patients) and compression of the L5 nerve (1 patient); these 3 patients required surgical retraction of the implant. At 3 years post-surgery, 1 patient required additional implants due to worsening symptoms. At a minimum of 24 months of follow-up (mean, 40 months), the treating surgeon was able to contact 45 patients. The mean pain score was 2 (1 to 10 scale), and 82% of patients had attained the minimal clinically important difference in pain score (defined as ≥2 of 10).
 
In 2016, results from a case series of 172 patients undergoing SIJ fusion reported to 2 years were published by Duhon Patientsnd colleagues (Duhon, 2016;6, Duhon,  2016;10) were formally enrolled in a single-arm trial (NCT01640353) with planned follow-up for 24 months. Success was defined as a reduction of VAS pain score of 20 mm (out of 100 mm), absence of device-related adverse events, absence of neurologic worsening, and absence of surgical re-intervention. Enrolled patients had a mean VAS pain score of 79.8, a mean ODI score of 55.2, and had 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 pre-specified 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. VAS pain score at 2 years was 26.0 and ODI score was 30.9. Thus, 1-year outcomes were maintained at 2 years. Other outcomes (eg, QOL scores) showed similar maintenance or slight improvement compared to 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.
 
In 2016, Polly and colleagues reported 2-year outcomes from the RCT of SIJ fusion (Polly, 2016). When reported, without an untreated control group, the study was a case series. Of 102 subjects originally assigned to SIJ fusion and treated, 89 (87%) were evaluated at 2 years. Although the clinical trial used a different composite end point, in this report, clinical outcomes were based on the amount of improvement in SIJ pain and in ODI scores. 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 in in 25 points in SIJ pain score or a score of 35 or less and an improvement of 18.8 points in ODI score. At 24 months, 83.1% and 82% had improvement and substantial improvement in SIJ pain score, and 68.2% and 65.9% had improvement and substantial improvement in ODI. By 24 months, the proportion taking opioids was reduced from 68.6% at baseline to 48.3%.
 
A 2014 report by Rudolph and Capobianco described 5-year follow-up for 17 of 21 consecutive patients treated at their institution between 2007 and 2009 (Rudolf, 2014). Of the 4 patients lost to follow-up, 2 had died and 1 had become quadriplegic due to severe neck trauma. For the remaining patients, mean VAS score (range, 0-10) improved from 8.3 before surgery to 2.4 at 5 years; 88.2% of patients had substantial clinical benefit, which was defined as a 2.5-point decrease in VAS score or a raw score less than 3.5. Mean ODI score at 5 years was 21.5. Imaging by radiograph and computed tomography showed intra-articular bridging in 87% of patients with no evidence of implant loosening or migration.
 
Case Series with Unknown Follow-Up Rates
The following case series did not report follow-up rates or study methodologies did not permit calculation of the complete number of patients treated.
 
In 2013, Smith and colleagues retrospectively compared open with minimally invasive SIJ fusion (Smith, 2013). Because all patients received fusion, this study should be interpreted as a case series, with attention paid to the minimally invasive fusion group. Only patients with medical records documenting 12- or 24-month pain scales were included, resulting in 114 patients selected for the minimally invasive group. Losses to follow-up could not be determined. At 12 months, VAS pain scores decreased to a mean of 2.3 from a baseline of 8.1. At 24 months, mean VAS pain score was 1.7, but data for only 38 patients were analyzed. These improvements in VAS pain score were greater than those for open fusion, but conclusions of comparative efficacy should not be made given this type of study. Implant repositioning was performed in 3.5% of patients in the minimally invasive group.
 
A large (N=144) industry-sponsored, multicenter retrospective series was reported by Sachs and colleagues (Sachs, 2014). Consecutive patients from 6 sites were included if preoperative and 12-month follow-up data were available. No information was provided on the total number of patients treated during the same time interval. Mean baseline pain score was 8.6. At a mean 16-month follow-up, VAS score was 2.7 (/10), an improvement of 6.1. Ten percent of patients reported an improvement of 1 point or less. Substantial clinical benefit, defined as a decrease in pain score by more than 2.5 points or a score of 3.5 or less, was reported in 91.9% of patients.
 
In 2016, Sachs and colleagues outcomes of 107 patients with a minimum follow-up of 3 years (Sachs, 2016). The number of potentially eligible patients was not reported, so the follow-up rate is unknown. Pain scores improved from a mean of 7.5 at baseline to 2.5 at a mean follow-up time of 3.7 years. ODI score at follow-up was 28.2, indicating moderate residual disability. Overall satisfaction rate was 87.9% (67.3% very satisfied, 20.6% somewhat satisfied). Revision surgery was reported in 5 (4.7%) patients. Without knowing the number of eligible patients, the validity of this study cannot be determined.
 
2018 Update
A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Sun et al published a meta-analysis of 7 studies that included patients with chronic SIJ pain who received treatment with cooled radiofrequency procedures (Sun, 2018). While overall outcomes were improved after treatment, there was heterogeneity across study designs and patient selection, which limited the strength of the meta-analysis. Also, sample sizes in the selected studies were small.
 
Darr et al published three-year follow-up results of the INSITE and Sacroiliac Joint Fusion with iFuse Implant System trials (Darr, 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.
 
Araghi et al 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 (Araghi, 2017). 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.
 
Cross et al 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 (Cross, 2018). 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 pre-procedure 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.

CPT/HCPCS:
22899Unlisted procedure, spine
27279Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device
27299Unlisted procedure, pelvis or hip joint

References: Araghi A, Woodruff R, Colle K, et al.(2017) Pain and opioid use outcomes following minimally invasive sacroiliac joint fusion with decortication and bone grafting: The Evolusion Clinical Trial. Open Orthop J. Feb 2017;11:1440-1448. PMID 29387289

Bina RW and Hurlbert RJ(2017) Sacroiliac fusion: another "Magic Bullet" destined for disrepute. Neurosurg Clin N Am. 2017 Jul;28(3):313-320.

Cross WW, Delbridge A, Hales D, et al.(2018) Minimally Invasive sacroiliac joint fusion: 2-year radiographic and clinical outcomes with a principles-based SIJ fusion system. Open Orthop J. Feb 2018;12:7-16. PMID 29430266

Darr E, Meyer SC, Whang PG, et al.(2018) Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2018;11:113-121. PMID 29674852

Duhon BS, Bitan F, Lockstadt H, et al.(2016) 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. PMID 27162715

Duhon BS, Cher DJ, Wine KD, et al.(2016) Triangular titanium implants for minimally invasive sacroiliac joint fusion: a prospective study. Global Spine J. May 2016;6(3):257-269. PMID 27099817

International Society for the Advancement of Spinal Surgery. Statement on coding changes for minimally invasive SI joint fusion. 2013. Available online at: http://www.isass.org/public_policy/2013-08-07-isass-statement-minimally-invasive-si-joint-fusion-coding-changes.html. Last accessed March, 2014.

Patel N.(2015) Twelve-Month Follow-Up of a Randomized Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Region Pain. Pain Pract. Jan 7 2015. PMID 25565322

Polly DW, Cher DJ, Wine KD, et al.(2015) Randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants vs nonsurgical management for sacroiliac joint dysfunction: 12-month outcomes. Neurosurgery. Nov 2015;77(5):674-691. PMID 26291338

Polly DW, Swofford J, Whang PG, et al.(2016) 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. PMID 27652199

Rudolf L, Capobianco R.(2014) Five-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion using triangular implants. Open Orthop J. 2014;8:375-383. PMID 25352932

Rudolf L.(2012) Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. Open Orthop J 2012; 6:495-502.

Sachs D, Capobianco R, Cher D, et al.(2014) One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis. Med Devices (Auckl). 2014;7:299-304. PMID 25210479

Sachs D, Kovalsky D, Redmond A, et al.(2016) Durable intermediate-to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2016;9:213-222. PMID 27471413

Sachs D., Capobianco R.(2012) One year successful outcomes for novel sacroiliac joint arthrodesis system. Ann Surg Innov Res 2012 Dec 27;6(1):13.

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Sturesson B, Kools D, Pflugmacher R, et al.(2016) Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. May 14 2016. PMID 27179664

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Wise CL., Dall BE.(2008) Minimally invasive sacroiliac arthrodesis: outcomes of a new technique. J Spinal Disord Tech. 2008 Dec;21(8):579-84.

Zheng Y, Gu M, Shi D, et al.(2014) Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for ankylosing spondylitis: a open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014;34(9):1195-1202. PMID 24518967


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