Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Response to Letter].
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SUBMITTER: Kranenburg A
PROVIDER: S-EPMC9587730 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
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Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Response to Letter].
Kranenburg Andy A Garcia-Diaz Gabriel G Cook Judson H JH Thambuswamy Michael M James Whitney W Stevens David D Bruggeman Adam A Chen Ying Y Capobianco Robyn R Reckling W Carlton WC Siegal Joel D JD
Medical devices (Auckland, N.Z.) 20221018
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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
Project description: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.
| S-EPMC6551609 | biostudies-literature
Project description:BackgroundIncreasing long-term evidence supports the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint (SIJ) dysfunction, an important cause of chronic low-back/buttock pain.ObjectiveTo report 4-year follow-up in patients undergoing SIJF using triangular titanium implants (TTI) as part of two prospective trials.MethodsWe enrolled 103 subjects at 12 centers treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and followed them in the current study (NCT02270203), with clinic visits at 3, 4, and 5 years.ResultsAt 4 years, mean SIJ pain scores (available in 91 subjects [88.3%]) had decreased by 54 points from baseline; disability (Oswestry Disability Index) scores decreased by 26 points; and quality of life (EuroQOL-5D) improved by 0.3 points (0-1 scale). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 43% at 4-year follow-up.ConclusionFour-year follow-up showed continued excellent responses in patients with SIJ pain treated with SIJF using triangular titanium implants.
| S-EPMC6120564 | biostudies-literature
Project description:Osteochondral allograft transplantation provides components of both cartilage and subchondral bone and can be used in large and multifocal defects where autologous procedures are limited by donor-site morbidity. Osteochondral allograft transplantation is particularly appealing in the management of failed cartilage repair, as larger defects and subchondral bone involvement are often present, and the use of multiple overlapping plugs might be considered. The described technique provides our preoperative workup and reproducible surgical approach for patients who have undergone previous osteochondral transplantation with graft failure and are young, active patients who would not be otherwise suited for a knee arthroplasty procedure.
| S-EPMC10066260 | biostudies-literature
Project description:ObjectiveThe aim was to identify the cost-effectiveness of minimally invasive sacroiliac joint fusion (MI SIJF) surgery with titanium triangular implants for patients with sacroiliac joint (SIJ) pain who have failed conservative management, compared to non-surgical management (NSM) from a National Health Service (NHS) England perspective.MethodsOver a time horizon of 5 years, a cohort state transition model compared the costs and outcomes of treating patients with MI SIJF to those of traditional NSM treatment pathways. The NSM arm included two treatments: grouped physical therapy and corticosteroid injections (PTSI) or radiofrequency ablation (RFA). Three different strategies were considered: (1) a stepped pathway, (2) patients split between PTSI and RFA, and (3) RFA only. The outcome measure was incremental cost-effectiveness ratio (ICER), reported in 2018 British pounds per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were used to test the robustness of the model results.ResultsPatients undergoing MI SIJF accrued total procedure-related and pain-management costs of £8358, while NSM treatment strategy 1 had total costs of £6880. The MI SIJF cohort had 2.98 QALYs compared to strategy 1 with 2.30 QALYs. This resulted in an ICER for MI SIJF versus strategy 1 of £2164/QALY gained. Strategy 2 of the NSM arm had lower costs than strategy 1 (£6564) and 2.26 QALYs, and this resulted in an ICER of £2468/QALY gained for MI SIJF. Strategy 3 of the NSM arm had lower costs than strategy 1 (£6580), and this resulted in 2.28 QALYs and an ICER of £2518/QALY gained for MI SIJF. Probabilistic sensitivity analysis shows that at a threshold of £20,000/QALY gained, MI SIJF has a probability of being cost-effective versus NSM strategies of 96%, 97%, and 91% for strategies 1, 2, and 3, respectively.ConclusionMI SIJF appears to be cost-effective over a 5-year time horizon when compared to traditional NSM pathways in an NHS context.
| S-EPMC8160075 | biostudies-literature
Project description:BackgroundStrong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.ObjectiveTo report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months.MethodsSIJF 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.Results84% 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.ConclusionIn 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 evidenceLevel II.
| S-EPMC8254553 | biostudies-literature
Project description:BackgroundMinimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain.ObjectiveThe objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively.MethodsA total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5 years.ResultsMean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI was 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. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3 years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3 years compared to earlier time points.ConclusionIn long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates.Level of evidenceLevel II.Clinical relevanceSIJF with TTI.
| S-EPMC5898880 | biostudies-literature
Project description:BackgroundSacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain.ObjectiveTo concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction.MethodsA 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.ResultsSix-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).ConclusionThis 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:IntroductionCranioplasty is a common neurosurgical procedure, but infections can complicate it, necessitating revision surgery. Alloplastic patient-specific implants (PSI) are increasingly utilized, and different materials are available. This study evaluates the role of titanium-reinforced calcium-phosphate (CaP:Ti) implants in revision cranioplasty.Research questionAssessing the efficacy and safety of CaP:Ti PSI in patients requiring revision cranioplasty following complications with previously failed cranioplasty attempts.Material and methodsRetrospective analysis of 15 patients who underwent CaP:Ti PSI implantation for revision cranioplasty between 2016 and 2022 at a single neurosurgical department. Data on demographics, perioperative details, and outcomes were collected and assessed. Differences in distribution were assessed using Fisher's exact test, and groups were numerically compared using student's t-test. A p-value <0.05 was considered statistically significant.ResultsIn most patients, CP failure occurred early (38 days) following elective craniotomy for tumor and vascular procedures. The first revision cranioplasty was conducted in 12 cases using CaP:Ti PSI in 8 cases successfully requiring no further revision. Three cases implanted with other alloplastic materials required revision and received CaP:Ti PSI in the second (n = 2) or third (n = 1) CP attempt. The overall success rate for CaP:Ti PSI was 73.3% over more than two years of follow-up. success rate in revision cranioplasty. Surgical site complications, predominantly infections, were the main cause of CP failure. The average interval between implant removal and re-cranioplasty was 300 days. Prehabilitation using skin expanders and postoperative antibiotic use were strategies successfully utilized in this cohort.Discussion and conclusionOur findings suggest that CaP:Ti PSI implants hold promise in salvaging complicated cranioplasty in most cases despite challenges such as infection and implant failure. The use of techniques like skin expanders may contribute to better outcomes. However, further research is crucial to establish optimal timing and patient selection guidelines in revision cranioplasty using CaP:Ti implants, which could significantly impact future neurosurgical practices.
| S-EPMC11910373 | biostudies-literature