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Background: Distraction arthrodesis (DA) and stabilization of the sacroiliac (SI) joint by placing standalone structural allograft (SA) into the joint from a posterior trajectory has recently been introduced as a surgical procedure for chronic SI joint pain refractory to non-operative care. Methods: Retrospective case series of patients with recurrent and/or persistent pain after placement of one or more interpositional/intraarticular standalone SAs between the ilium and sacrum using a posterior procedure to treat SI joint pain/dysfunction. Patients subsequently underwent surgical revision with porous titanium fusion implants using a lateral transfixing procedure. The demographic, clinical, and radiographic features of these cases are described. Results: Data were available for 37 patients. The average (SD) age was 57 (13) years, 62% were female, and the average BMI was 31 (5.4). On average, two SA implants were placed per joint; 46% of cases were bilateral. At follow-up, two common themes were identified: lucencies around the implants and suboptimal implant position. None of the cases showed radiographic fusion of the SI joint prior to revision. One patient had an inflammatory reaction to the SA. All patients presented for revision due to either continued (49%) or recurrence (51%) of pain. In one revision case, the SA was forced ventrally, resulting in a sacral fracture, which was treated conservatively without sequelae. Conclusions: The popularity of standalone SA for SI joint stabilization/fusion with a posterior procedure is increasing. This case series demonstrates that clinical failures from this procedure may require surgical revision. The proposed fusion strategy (DA) for these products is unproven in the SI joint, and, therefore, properly conducted prospective randomized clinical trials with long-term clinical and radiographic follow-up are important to establish the safety and efficacy of this approach. In the meantime, the placement of lateral titanium implants appears to be an effective revision strategy.
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BACKGROUND: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months. METHODS: SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits. RESULTS: 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0-100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. CONCLUSION: In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events. LEVEL OF EVIDENCE: Level II.
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BACKGROUND: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To assess the safety and effectiveness of SIJF using a 3D-printed TTI. METHODS: Fifty-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. RESULTS: Ninety 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. CONCLUSION: In 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 EVIDENCE: Level II.
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Background: Minimally invasive sacroiliac joint (SIJ) fusion (SIJF) has become an increasingly accepted surgical option for chronic SI joint dysfunction, a prevalent cause of chronic low back/buttock pain. Objective: To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction. Methods: A total of 28 subjects with SIJ dysfunction at 8 centers underwent SIJF with 3D TTI and had scheduled follow-up to 6 months (NCT03122899). Results: Mean preoperative SIJ pain score was 79.1 and mean preoperative Oswestry Disability Index (ODI) was 49.9. At 6 months, pain scores decreased by 51 points and ODI decreased by 23.6 points (both p<0.0001). The proportion of subjects able to perform various back/pelvis-related physical functions with minimal difficulty improved significantly for nearly all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved. Conclusion: Early results from this prospective multicenter trial confirm that clinical responses to a 3D triangular titanium implant for SIJF are similar to those from prior trials, with improved physical function and decreased opioid use. Level of evidence: Level II.
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BACKGROUND: Rigid interspinous process fixation (ISPF) has received consideration as an efficient, minimally disruptive technique in supporting lumbar interbody fusion. However, despite advantageous intraoperative utility, limited evidence exists characterizing midterm to long-term clinical outcomes with ISPF. The objective of this multicenter study was to prospectively assess patients receiving single-level anterior (ALIF) or lateral (LLIF) lumbar interbody fusion with adjunctive ISPF. METHODS: This was a prospective, randomized, multicenter (11 investigators), noninferiority trial. All patients received single-level ALIF or LLIF with supplemental ISPF (n = 66) or pedicle screw fixation (PSF; n = 37) for degenerative disc disease and/or spondylolisthesis (grade ≤2). The randomization patient ratio was 2:1, ISPF/PSF. Perioperative and follow-up outcomes were collected (6 weeks, 3 months, 6 months, and 12 months). RESULTS: For ISPF patients, mean posterior intraoperative outcomes were: blood loss, 70.9 mL; operating time, 52.2 minutes; incision length, 5.5 cm; and fluoroscopic imaging time, 10.4 seconds. Statistically significant improvement in patient Oswestry Disability Index scores were achieved by just 6 weeks after operation (P < .01) and improved out to 12 months for the ISPF cohort. Patient-reported 36-Item Short Form Health Survey and Zurich Claudication Questionnaire scores were also significantly improved from baseline to 12 months in the ISPF cohort (P < .01). A total of 92.7% of ISPF patients exhibited interspinous fusion at 12 months. One ISPF patient (1.5%) required a secondary surgical intervention of possible relation to the posterior instrumentation/procedure. CONCLUSION: ISPF can be achieved quickly, with minimal tissue disruption and complication. In supplementing ALIF and LLIF, ISPF supported significant improvement in early postoperative (≤12 months) patient-reported outcomes, while facilitating robust posterior fusion.
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Anterior cervical procedures for neurologic decompression and fusion, including cervical diskectomy and cervical corpectomy, are commonly performed by orthopaedic surgeons and spinal neurosurgeons. These procedures are highly successful in treating most patients with persistent pain and neurologic symptoms that have not responded to nonsurgical methods. Adverse events occur infrequently, but several have been described, including esophageal injury, vertebral artery injury, dural tear, postoperative airway compromise, spinal cord injury, hematoma, dysphagia, dysphonia, and graft dislodgement. Newer procedures, such as cervical total disk replacement and the use of bone morphogenetic protein as a supplement to fusion, have raised unique concerns. Appropriate strategies must be utilized to avoid these adverse events, and the treating surgeon should have an understanding of how to detect and manage such events when they do arise.
