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.
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ABSTRACT:
SUBMITTER: Himstead AS
PROVIDER: S-EPMC8253473 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Sacroiliac joint fusions (SIJF) have been the subject of many research studies. The technical success of an SIJF is in part determined by whether osseous bridging occurs across the sacroiliac joint (SIJ). However, no validated SIJF assessment method has been described. Our objective was to document previously described SIJF assessment methods and define and validate a detailed assessment system for SIJF. Our results are only intended to establish computed tomography (CT)-based guidelines for SIJF to be used in a subsequent large clinical study to correlate them with clinical outcomes. The SIJF literature was reviewed to document previous descriptions of SIJF assessments. A detailed system was then developed for assessing SIJF from CT exams. To provide data that can be used to address a range of research questions, the system included assessing bridging bone relative to the SIJ anatomy, bridging bone immediately adjacent to the threaded implants crossing the joint, as well as bridging bone close to but not immediately adjacent to the implants. The system was applied to assessing SIJF from thin-slice CT exams in 19 patients 12 months following surgery. Two experienced radiologists implemented the assessment system, and in the event of a disagreement, an adjudicator was used. Most prior studies provide very little detail about how SIJF was assessed. Using the new assessment system, the agreement between the primary readers was substantial (0.67 using Gwet's AC1 statistic). Bridging bone representing a fusion of the SIJ was identified in most patients both immediately adjacent to the threaded implants crossing the joint, as well as distant to the implants. A detailed radiographic assessment system proved to be applicable to SIJF. The assessment system includes explicit language describing the location and extent of bridging bone across the SIJ. Standardization of the assessment of the SIJFs may allow for a more meaningful comparison of data between studies.
| S-EPMC5738220 | biostudies-literature
Project description:BackgroundSacroiliac joint (SIJ) disorders are common in patients with chronic lower back pain. Minimally invasive surgical options have been shown to be effective for the treatment of chronic SIJ dysfunction.ObjectiveTo determine the cost-effectiveness of minimally invasive SIJ fusion.MethodsData from two prospective, multicenter, clinical trials were used to inform a Markov process cost-utility model to evaluate cumulative 5-year health quality and costs after minimally invasive SIJ fusion using triangular titanium implants or non-surgical treatment. The analysis was performed from a third-party perspective. The model specifically incorporated variation in resource utilization observed in the randomized trial. Multiple one-way and probabilistic sensitivity analyses were performed.ResultsSIJ fusion was associated with a gain of approximately 0.74 quality-adjusted life years (QALYs) at a cost of US$13,313 per QALY gained. In multiple one-way sensitivity analyses all scenarios resulted in an incremental cost-effectiveness ratio (ICER) <$26,000/QALY. Probabilistic analyses showed a high degree of certainty that the maximum ICER for SIJ fusion was less than commonly selected thresholds for acceptability (mean ICER =$13,687, 95% confidence interval $5,162-$28,085). SIJ fusion provided potential cost savings per QALY gained compared to non-surgical treatment after a treatment horizon of greater than 13 years.ConclusionCompared to traditional non-surgical treatments, SIJ fusion is a cost-effective, and, in the long term, cost-saving strategy for the treatment of SIJ dysfunction due to degenerative sacroiliitis or SIJ disruption.
| S-EPMC4690648 | biostudies-literature
Project description:BackgroundFor a substantial part of patients with chronic low back pain, the origin is located in the sacroiliac joint (SIJ). Minimally invasive sacroiliac joint fusion (MISJF) is increasingly being implemented as a treatment option in SIJ dysfunction. Despite remaining controversy, evidence continues to increase. This study evaluates the clinical results and safety of MISJF in a double-center consecutive case series in patients with SIJ dysfunction over a one-year observation period.MethodsSIJ complaints were diagnosed after history taking, physical examination and least a 50% reduction of SIJ pain 30-60 min following image-guided injection. Primary outcome measures were patient reported outcome measurements (PROMs), consisting of Visual Analogue Scale (VAS) pain score and EuroQol 5-dimensions 3-levels (EQ-5D-3L). Patients' perspectives on the effects of surgery were collected through questionnaires. Secondary outcome measures were implant positioning and (serious) adverse events ((S)AE's).ResultsA total of 29 patients were included. In 44.8% of patients, SIJ dysfunction was of postpartum origin. The mean VAS-pain score improved from 7.83 (± 1.71) to 4.97 (± 2.63) postoperatively (p < 0.001). EQ-5D-3L score improved from 0.266 (± 0.129) to 0.499 (± 0.260) postoperatively (p < 0.001). Opioid consumption decreased from 44.8 to 24.1% postoperatively (p = 0.026). In 13.7% of patients, an (S)AE occurred.ConclusionMISJF appears to be an effective and safe procedure in this cohort. Statistically significant and clinically relevant improvements in pain and quality of life were observed one-year postoperatively. Future studies should focus on the long-term outcomes to further evaluate the safety and effectiveness of MISJF.
| S-EPMC9794474 | biostudies-literature
Project description:BACKGROUND:The evidence base supporting minimally invasive sacroiliac (SI) joint fusion (SIJF) surgery is increasing. The work relative value units (RVUs) associated with minimally invasive SIJF are seemingly low. To date, only one published study describes the relative work intensity associated with minimally invasive SIJF. No study has compared work intensity vs other commonly performed spine surgery procedures. METHODS:Charts of 192 patients at five sites who underwent either minimally invasive SIJF (American Medical Association [AMA] CPT® code 27279) or lumbar microdiscectomy (AMA CPT® code 63030) were reviewed. Abstracted were preoperative times associated with diagnosis and patient care, intraoperative parameters including operating room (OR) in/out times and procedure start/stop times, and postoperative care requirements. Additionally, using a visual analog scale, surgeons estimated the intensity of intraoperative care, including mental, temporal, and physical demands and effort and frustration. Work was defined as operative time multiplied by task intensity. RESULTS:Patients who underwent minimally invasive SIJF were more likely female. Mean procedure times were lower in SIJF by about 27.8 minutes (P<0.0001) and mean total OR times were lower by 27.9 minutes (P<0.0001), but there was substantial overlap across procedures. Mean preservice and post-service total labor times were longer in minimally invasive SIJF (preservice times longer by 63.5 minutes [P<0.0001] and post-service labor times longer by 20.2 minutes [P<0.0001]). The number of postoperative visits was higher in minimally invasive SIJF. Mean total service time (preoperative + OR time + postoperative) was higher in the minimally invasive SIJF group (261.5 vs 211.9 minutes, P<0.0001). Intraoperative intensity levels were higher for mental, physical, effort, and frustration domains (P<0.0001 each). After taking into account intensity, intraoperative workloads showed substantial overlap. CONCLUSION:Compared to a commonly performed lumbar spine surgical procedure, lumbar microdiscectomy, that currently has a higher work RVU, preoperative, intraoperative, and postoperative workload for minimally invasive SIJF is higher. The work RVU for minimally invasive SIJF should be adjusted upward as the relative amount of work is comparable.
| S-EPMC4968979 | biostudies-literature
Project description:The index 2014 ISASS Policy Statement - Minimally Invasive Sacroiliac Joint Fusion was generated out of necessity to provide an ICD9-based background and emphasize tools to ensure correct diagnosis. A timely ICD10-based 2016 Update provides a granular threshold selection with improved level of evidence and a more robust, relevant database.
| S-EPMC5027819 | biostudies-literature
Project description:In recent years, many studies have focused on the host immune system and its relationship with tumor progression in a variety of solid tumors, including breast cancer. This study investigates recent trends of immunotherapy research in breast cancer and compares the contributions of research from different regions, institutions, and authors. A search of breast cancer and immunotherapy studies that were published between 2010 and 2019-with different keyword combinations-was performed in the Web of Science database. Bibliometric data were collected for analysis. VOSviewer software was used to generate a figure for the keyword's co-occurrence network, so as to implement network visualization analysis. A total of 1,041 publications were identified. The United States and China contributed to approximately 50% of the publications, 336 and 208, respectively. Both countries drove the increase in publications after 2015. A paper entitled "Pembrolizumab in patients with advanced triple-negative breast cancer: Phase IB KEYNOTE-012 Study" that was published in the Journal of Clinical Oncology by Nanda et al. was the most cited (715 citations). The keywords found in this research were grouped into four clusters: "mechanism," "vaccination," "PD-L1," and "chemotherapy." The terms "tumor-infiltrating lymphocytes" and "PD-1/PD-L1" are among the latest hotspots, which mostly appeared in 2017. Author keyword analysis revealed that recent trends in breast cancer immunotherapy focus on the triple-negative breast cancer subtype and PD-1/PD-L1 immune checkpoint pathway and inhibitors. This study analyzed global trends in immunotherapy research on breast cancer over the past 10 years and provided insight into the features and research hotspots of the articles in this issue.
| S-EPMC7661143 | biostudies-literature
Project description:STUDY DESIGN: Systematic reviewObjective: To compare the safety and effectiveness of fusion versus denervation for chronic sacroiliac joint pain after failed conservative management. SUMMARY OF BACKGROUND: METHODS of confirming the sacroiliac joint as a pain source have been extensively studied and reported in the literature. After confirmation of the origin of the pain by positive local anesthetic blocks, chronic sacroiliac joint pain is usually managed with a combination of medication, physical therapies, and injections. We have chosen to compare two alternative treatments for sacroiliac pain that was refractory to conservative therapies. METHODS: A systematic review of the English-language literature was undertaken for articles published between 1970 and June 2010. Electronic databases and reference lists of key articles were searched to identify studies evaluating fusion or denervation for chronic sacroiliac joint pain after failed conservative management. Studies involving only conservative treatment or traumatic onset of injury were excluded. Two independent reviewers assessed the level of evidence quality using the grading of recommendations assessment, development and evaluation (GRADE) system, and disagreements were resolved by consensus. RESULTS: We identified eleven articles (six fusion, five denervation) meeting our inclusion criteria. The majority of patients report satisfaction after both treatments. Both treatments reported mean improvements in pain and functional outcome. Rates of complications were higher among fusion studies (13.7%) compared to denervation studies (7.3%). Only fusion studies reported infections (5.3%). No infections were reported among denervation patients. The evidence for all findings were very low to low; therefore, the relative efficacy or safety of one treatment over another cannot be established. CONCLUSIONS: Sacroiliac joint fusion or denervation can reduce pain for many patients. Whether a true arthrodesis of the joint is achieved by percutaneous techniques is open to question and whether denervation of the joint gives durable pain relief is not clear. Further comparative studies of these two techniques may provide the answers.
| S-EPMC3427958 | biostudies-other
Project description:BACKGROUND:Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE:To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS:A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS:Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (? 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION:This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.
| S-EPMC4605280 | biostudies-literature
Project description:BackgroundPrior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.ObjectiveTo assess the safety and effectiveness of SIJF using a 3D-printed TTI.MethodsFifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints.ResultsNinety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p<.0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P<.0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence.ConclusionIn this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed.Level of evidenceLevel II.
| S-EPMC7305828 | biostudies-literature
Project description:Study Design Prospective multicenter single-arm interventional clinical trial. Objective To determine the degree of improvement in sacroiliac (SI) joint pain, disability related to SI joint pain, and quality of life in patients with SI joint dysfunction who undergo minimally invasive SI joint fusion using triangular-shaped titanium implants. Methods Subjects (n = 172) underwent minimally invasive SI joint fusion between August 2012 and January 2014 and completed structured assessments preoperatively and at 1, 3, 6, and 12 months postoperatively, including a 100-mm SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQOL-5D. Patient satisfaction with surgery was assessed at 6 and 12 months. Results Mean SI joint pain improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively (mean improvements of 49.9 and 49.1 points, p < 0.0001 each). Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each). SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001). 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. Conclusions Minimally invasive SI joint fusion resulted in improvement of pain, disability, and quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption.
| S-EPMC4836932 | biostudies-literature