Accurate placement of thoracolumbar pedicle screws using a handheld iOS-based navigation device: a prospective intra-patient agreement study.

BACKGROUND: Accurate pedicle screw placement is a challenge with reported misplacement rates of 10% and higher. A handheld navigation device (HND) may provide accuracy equal to CT-based navigation (CT-Nav) but without the cost and complexity. OBJECTIVE: To study the accuracy of a handheld navigation device for pedicle screw placement. STUDY DESIGN: This prospective cross-sectional study with consistently applied reference standard enrolled 20 patients undergoing 92 pedicle screw placements. PATIENTS: Patients who underwent pedicle screw placement between May 2022 and September 2022. OUTCOME MEASURES: Pedicle screw placement accuracy per Gertzbein-Robbins. METHODS: Once the screw pilot hole was established, the proposed trajectory of the HND was compared with that proposed by CT-Nav. Postoperatively, screw accuracy was graded according to Gertzbein-Robbins by a blinded radiologist based on CT scans. Accuracy was compared between the two systems and to published control for fluoroscopy assisted and CT-Nav placement using Bayesian posterior distribution. RESULTS: The trajectory proposed by the HND and CT-Nav were in agreement in 98.9% (95% Exact CI; 94.09% - 99.97%). The HND accuracy was 98.9% with 91 screws rated "A" and 1 rated "C". Non-inferiority to fluoroscopic placement was achieved because the one-sided normal-approximation 95% CI Lower Bound (LB) of 95.3% is greater than the Performance Goal (PG) of 83.4%. Post-hoc analysis demonstrated that the probability of superiority of the HND relative to the historical accuracy rate of 91.5% for fluoroscopy assisted procedures is > 0.999 and that the HND's accuracy rate is within 4.5% of CT-Nav of 95.5% is >0.999. No adverse events or intra-operative complications associated with HND were observed. There was 1 (1.1%) intra-operative repositioning and no re-operations for any reason. CONCLUSIONS: The accuracy rate of the HND was 98.9%, and the proposed trajectory matched with CT-Nav in 98.9% of the time. This is superior to the historical published accuracy rate for fluoroscopy-assisted procedures and equivalent to the historical published accuracy rate for CT-Nav. CLINICAL TRIAL REGISTRATION NUMBER: Dutch Trial Register NL74268.058.20.

Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint.

BACKGROUND: Sacroiliac joint pain is increasingly recognized as a cause of low back pain. We compared the safety and effectiveness of minimally invasive sacroiliac joint arthrodesis using triangular titanium implants and conservative management in patients with chronic sacroiliac joint pain. METHODS: This study was a prospective, multicenter randomized controlled trial of adults with chronic sacroiliac joint pain assigned to either conservative management or sacroiliac joint arthrodesis with triangular titanium implants. The study end points included self-rated low back pain (visual analog scale [VAS]), back dysfunction (Oswestry Disability Index [ODI]), and quality of life. Ninety percent of subjects in both groups completed the study. RESULTS: Between June 6, 2013, and May 15, 2015, 103 subjects were randomly assigned to conservative management (n = 51) or sacroiliac joint arthrodesis (n = 52). At 2 years, the mean low back pain improved by 45 points (95% confidence interval [CI], 37 to 54 points) after sacroiliac joint arthrodesis and 11 points (95% CI, 2 to 20 points) after conservative management, with a mean difference between groups of 34 points (p < 0.0001). The mean ODI improved by 26 points (95% CI, 21 to 32 points) after sacroiliac joint arthrodesis and 8 points (95% CI, 2 to 14 points) after conservative management, with a mean difference between groups of 18 points (p < 0.0001). Parallel improvements were seen in quality of life. In the sacroiliac joint arthrodesis group, the prevalence of opioid use decreased from 56% at baseline to 33% at 2 years (p = 0.009), and no significant change was observed in the conservative management group (47.1% at baseline and 45.7% at 2 years). Subjects in the conservative management group, after crossover to the surgical procedure, showed improvements in all measures similar to those originally assigned to sacroiliac joint arthrodesis. In the first 6 months, the frequency of adverse events did not differ between groups (p = 0.664). By month 24, we observed 39 severe adverse events after sacroiliac joint arthrodesis, including 2 cases of sacroiliac joint pain, 1 case of a postoperative gluteal hematoma, and 1 case of postoperative nerve impingement. The analysis of computed tomographic (CT) imaging at 12 months after sacroiliac joint arthrodesis showed radiolucencies adjacent to 8 implants (4.0% of all implants). CONCLUSIONS: For patients with chronic sacroiliac joint pain due to joint degeneration or disruption, minimally invasive sacroiliac joint arthrodesis with triangular titanium implants was safe and more effective throughout 2 years in improving pain, disability, and quality of life compared with conservative management. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Risk Factors for Continued Opioid Use in Conservative Versus Surgical Management of Low Back Pain Originating From the Sacroiliac Joint.

STUDY DESIGN: Secondary analysis of data from a randomized controlled trial. OBJECTIVES: To identify risk factors for continued opioid use after conservative management (CM) or minimally invasive surgical management (MISM) of low back pain (LBP) originating from the sacroiliac joint. METHODS: Patients were randomized either to CM (n = 49) or MISM (n = 52). We documented opioid use, pain intensity (visual analogue scale [VAS]), Oswestry Disability Index (ODI), and the Zung depression score (Zung Self-Rating Depression Scale) at baseline and at months 3 and 6 after treatment initiation. RESULTS: Compared with opioid nonusers, opioid users at baseline had higher mean levels of disability (ODI 61.5, standard deviation [SD] 13.3 vs ODI 51.5, SD 12.8; P < .01) and higher depression scores (Zung 48.5, SD 8.5, vs Zung 42.2, SD 7.2; P < .01). At 6 months, opioid users had higher 6-month pain levels (VAS 60.4, SD 24.0, vs VAS 42.4, SD 28.2; P < .01), higher disability scores (ODI 50.5, SD 16.2, vs ODI 32.7, SD 19.3; P < .01) and higher depression scores (Zung 47.6, SD 8.0, vs Zung 38.8, SD 8.9; P < .01). Risk factors for continued opioid use at 6 months were patient age (odds ratio [OR] for age = 0.91; P = .02) and an increase in LBP (OR 1.08; P = .02) in the CM group and a lack of improvement in depression scores (OR 1.12; P = .03) in the MISM group. CONCLUSIONS: In our patient cohort, the risk of continued opioid use in the treatment of LBP increased not only with pain intensity but also with levels of depression during the course of treatment.

1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain.

BACKGROUND: Low back pain (LBP) emanating from the sacroiliac joint (SIJ) is a common finding. Devices to fuse the SIJ are now commercially available, but high-quality evidence supporting their effectiveness is limited. OBJECTIVES: To compare the safety and effectiveness of conservative management (CM) to minimally invasive sacroiliac joint fusion (SIJF) in patients with chronic LBP originating from the SIJ. STUDY DESIGN: Prospective, multicenter randomized controlled trial. SETTING: One hundred three adults in spine clinics with chronic LBP originating from the SIJ. METHODS: Patients were randomly assigned to CM (n = 51) or SIJF using triangular titanium implants (n = 52). CM consisted of optimization of medical therapy, individualized physiotherapy, and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated LBP at 6 months using a 0 - 100 visual analog scale (VAS). Other effectiveness and safety endpoints, including leg pain, disability using Oswestry Disability Index (ODI), quality of life using EQ-5D, and SIJ function using active straight leg raise test (ASLR), were assessed up to 12 months. RESULTS: At 12 months, mean LBP improved by 41.6 VAS points in the SIJF group vs. 14.0 points in the CM group (treatment difference of 27.6 points, P < 0.0001). Mean ODI improved by 25.0 points in the SIJF group vs. 8.7 points in the CM group (P < 0.0001). Mean improvements in leg pain and EQ-5D scores were large after SIJF and superior to those after CM. CM patients were allowed to crossover to SIJF after 6 months. Patients who crossed to surgical treatment had no pre-crossover improvement in pain and ODI scores; after crossover, improvements were as large as those originally assigned to SIJF. One case of postoperative nerve impingement occurred in the surgical group. Two SIJF patients had recurrent pain attributed to possible device loosening and one had postoperative hematoma. In the CM group, one crossover surgery patient had recurrent pain requiring a revision surgery. LIMITATIONS: The primary limitation was lack of blinding and the subjective nature of self-assessed outcomes. CONCLUSIONS: For patients with chronic LBP originating from the SIJ, minimally invasive SIJF with triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, and improving patient function and quality of life. Our findings will help to inform decisions regarding its use as a treatment option in this patient population.Key words: Sacroiliac joint dysfunction, pelvic girdle pain, randomized controlled trial, quality of life, spine implants.

Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial.

BACKGROUND: The first results from the randomized, controlled iFuse Implant System Minimally Invasive Arthrodesis (iMIA) trial showed that minimally invasive surgical management (MISM) of low back pain originating from the sacroiliac joint (SIJ) by placing transarticular triangular titanium implants reduced pain more effectively than conservative management (CM). We now conducted a separate analysis of the iMIA data to assess whether the referred leg pain (RLP) component of SIJ-associated pain may also be affected by MISM or CM. METHODS: Data from 101 patients, recruited between June 2013 and May 2015 at nine European spine care centers, were included. Forty-nine patients were randomized to CM and 51 patients to MISM. RLP was defined as pain below the gluteal fold and assessed using the visual analogue scale (VAS). Changes in RLP over 6 months were the primary endpoint. RESULTS: The prevalence of clinically significant RLP was 76.2 %. Over 6 months of follow-up, CM produced no significant change in RLP, which was 51.0 VAS points (interquartile range (IQR) 17.0-75.0) at baseline. In contrast, in the MISM cohort, we found a significant decrease in RLP from VAS 58.0 (IQR 24.5-80.0) at baseline to VAS 13.5 (IQR 0.0-39.3) after 6 months (p < 0.01). Improvement of RLP was associated only with the type of treatment (OR 5.04, p < 0.01), but not with patient age, sex, or different patterns of pain referral. CONCLUSIONS: Our analysis shows that RLP is a frequent phenomenon in patients with SIJ-associated pain. At 6 months of follow-up, MISM helped relieve RLP more effectively than CM. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01741025.