Triangular Implants Research Articles

Navigated Simultaneous Lateral Minimally Invasive Tubular and Posterior Mini-Open Access for Removal and Revision of Triangular Sacroiliac Joint Implants: A Technical Note

Sacroiliac joint (SIJ) fusion, to treat back pain caused by SIJ dysfunction, can employ open or minimally invasive surgery (MIS) techniques and either cylindrical (screw-shaped) or triangular (wedge-shaped) implants. Fusion nonunion sometimes explains recurrent SIJ pain following fusion and occasionally requires hardware revision. MIS revision minimizes patient pain, infection, and disability, but due to the triangular implant size and form factor, implant removal can present challenges for MIS access during the explantation and achieving good bony purchase for reinstrumentation. Here, we report a prone single-position lateral MIS/posterior mini-open procedure for triangular-implant SIJ fusion revision. The patient is a 72-year-old female who underwent right SIJ fusion for lower back and leg pain sustained after a fall 2 years prior but experienced recurrent pain over the subsequent 2 years, with imaging findings of right SIJ peri-hardware lucencies and diagnostic injections confirming persistent right-sided sacroiliitis. The patient underwent hardware removal using the lateral MIS incision with table-mounted tubular access and image-guided navigation to maintain exposure, plus simultaneous reinstrumentation using a navigated S2-alar-iliac screw and iliac bolt construct with connecting rod through the posterior mini-open incision made for the navigation reference frame spinous process clamp. The use of navigation and MIS access can significantly decrease the complexity of lateral hardware removal, and mini-open navigated screw-and-rod constructs offer reinstrumentation options accessible to surgeons unfamiliar with specialized posterior SIJ systems.

Return to Duty inMilitary Service Members Following Minimally Invasive Sacroiliac Joint Fusion.

As the utilization of minimally invasive sacroiliac joint fusion (SIJF) continues to expand, a better understanding of postoperative outcomes is needed, particularly in young and active individuals. The purpose of this study is to assess the outcomes of this procedure in an active duty military population by examining return-to-duty (RTD) rates. A retrospective review of the electronic medical record from a tertiary military medical center was performed for active duty service members undergoing SIJF from January 2013 to January 2019. The primary outcome measured was RTD at 6 months, with active duty status at 1 year, last follow-up, and revision surgery as secondary outcomes. Demographic and surgical variables recorded included patient age, gender, military rank, utilization of navigation, and implant type. Sixteen service members met the inclusion criteria, with a mean age of 40.5 ± 6.7 years. The mean follow-up after surgery was 24 ± 15 months. Patients received either cylindrical (n = 6) or triangular (n = 10) implants placed with (n = 6) or without (n = 10) navigation. Within 6 months of surgery, 56% of patients were able to RTD. Patients undergoing navigation-assisted procedures were significantly more likely to RTD at 6 months (100% vs. 30%, P = .011) compared to those undergoing surgery performed with orthogonal fluoroscopic imaging. Compared to those with cylindrical implants, patients with triangular implants were also more likely to RTD at 6 months (80% vs. 17%, P = .035). Following SIJF, a small majority of service members were able to return to full active duty status by 6 months. Further studies are needed to assess the potential benefits of navigation and implant selection, as our retrospective review noted differences in outcomes based on these variables.

Stability and Instrumentation Stresses Among Sacropelvic Fixation Techniques With Novel Porous Fusion/Fixation Implants: A Finite Element Study.

Sacropelvic fixation is frequently combined with thoracolumbar instrumentation for correcting spinal deformities. This study aimed to characterize sacropelvic fixation techniques using novel porous fusion/fixation implants (PFFI). Three T10-pelvis finite element models were created: (1) pedicle screws and rods in T10-S1, PFFI bilaterally in S2 alar-iliac (S2AI) trajectory; (2) fixation in T10-S1, PFFI bilaterally in S2AI trajectory, triangular implants bilaterally above the PFFI in a sacro-alar-iliac trajectory (PFFI-IFSAI); and (3) fixation in T10-S1, PFFI bilaterally in S2AI trajectory, PFFI in sacro-alar-iliac trajectory stacked cephalad to those in S2AI position (2-PFFI). Models were loaded with pure moments of 7.5 Nm in flexion-extension, lateral bending, and axial rotation. Outputs were compared against 2 baseline models: (1) pedicle screws and rods in T10-S1 (PED), and (2) pedicle screws and rods in T10-S1, and S2AI screws. PFFI and S2AI resulted in similar L5-S1 motion; adding another PFFI per side (2-PFFI) further reduced this motion. Sacroiliac joint (SIJ) motion was also similar between PFFI and S2AI; PFFI-IFSAI and 2-PFFI demonstrated a further reduction in SIJ motion. Additionally, PFFI reduced max stresses on S1 pedicle screws and on implants in the S2AI position. The study shows that supplementing a long construct with PFFI increases the stability of the L5-S1 and SIJ and reduces stresses on the S1 pedicle screws and implants in the S2AI position. The findings suggest a reduced risk of pseudarthrosis at L5-S1 and screw breakage. Clinical studies may be performed to demonstrate applicability to patient outcomes. Not applicable (basic science study).

Effect of Sacropelvic Hardware on Axis and Center of Rotation of the Sacroiliac Joint: A Finite Element Study.

The sacroiliac joint (SIJ) transfers the load of the upper body to the lower extremities while allowing a variable physiological movement among individuals. The axis of rotation (AoR) and center of rotation (CoR) of the SIJ can be evaluated to analyze the stability of the SIJ, including when the sacrum is fixed. The purpose of this study was to determine how load intensity affects the SIJ for the intact model and to characterize how sacropelvic fixation performed with different techniques affects this joint. Five T10-pelvis models were used: (1) intact model; (2) pedicle screws and rods in T10-S1; (3)pedicle screws and rods in T10-S1, and bilateral S2 alar-iliac screws (S2AI); (4) pedicle screws and rods in T10-S1, bilateral S2AI screws, and triangular implants inserted bilaterally in a sacral alar-iliac trajectory ; and (5) pedicle screws and rods in T10-S1, bilateral S2AI screws, and 2 bilateral triangular implants inserted in a lateral trajectory. Outputs of these models under flexion-extension were compared: AoR and CoR of the SIJ at incremental steps from 0 to 7.5 Nm for the intact model and AoR and CoR of the SIJ for the instrumented models at 7.5 Nm. The intact model was validated against an in vivo study by comparing range of motion and displacement of the sacrum. Increasing the load intensity for the intact model led to an increase of the rotation of the sacrum but did not change the CoR. Comparison among the instrumented models showed that sacropelvic fixation techniques reduced the rotation of the sacrum and stabilized the SIJ, in particular with triangular implants. The study outcomes suggest that increasing load intensity increases the rotation of the sacrum but does not influence the CoR, and use of sacropelvic fixation increases the stability of the SIJ, especially when triangular implants are employed. The choice of the instrumentation strategy for sacropelvic fixation affects the stability of the construct in terms of both range of motion and axes of rotation, with direct consequences on the risk of failure and mobilization. Clinical studies should be performed to confirm these biomechanical findings.

Probing the Influence of Hybrid Thread Design on Biomechanical Response of Dental Implants: Finite Element Study and Experimental Validation.

This study aimed to perform quantitative biomechanical analysis for probing the effect of varying thread shapes in an implant for improved primary stability in prosthodontics surgery. Dental implants were designed with square (SQR), buttress (BUT), and triangular (TRI) thread shapes or their combinations. Cone-beam computed tomography images of mandible molar zones in human subjects belonging to three age groups were used for virtual implantation of the designed implants, to quantify patient-specific peri-implant bone microstrain, using finite element analyses. The in silico analyses were carried out considering frictional contact to simulate immediate loading with a static masticatory force of 200 N. To validate computational biomechanics results, compression tests were performed on three-dimensional printed implants having the investigated thread architectures. Bone/implant contact areas were also quantitatively assessed. It was observed that, bone/implant contact was maximum for SQR implants followed by BUT and TRI implants. For all the cases, peak microstrain was recorded in the cervical cortical bone. The combination of different thread shapes in the middle or in the apical part (or both) was demonstrated to improve peri-implant microstrain, particularly for BUT and TRI. Considering 1500-2000 microstrain generates in the peri-implant bone during regular physiological functioning, BUT-SQR, BUT-TRI-SQR, TRI-SQR-BUT, SQR, and SQR-BUT-TRI design concepts were suitable for younger; BUT-TRI-SQR, BUT-SQR-TRI, TRI-SQR-BUT, SQR-BUT, SQR-TRI for middle-aged, and BUT-TRI-SQR, BUT-SQR-TRI, TRI-BUT-SQR, SQR, and SQR-TRI for the older group of human patients.

P18. Characterization of sacropelvic fixation using novel porous fusion/fixation implants in combination with thoracolumbar instrumentation

<h3>BACKGROUND CONTEXT</h3> Sacropelvic fixation is often used at the distal end of long constructs in adult deformity surgery in order to provide biomechanical support to the base of the constructs, with the aim of reducing complications such as pseudarthrosis of the L5-S1 joint and hardware failure or loosening. <h3>PURPOSE</h3> The objective of this study was to investigate configurations in which a porous fusion/fixation (PFF) implant was employed to enhance sacropelvic fixation. <h3>STUDY DESIGN/SETTING</h3> Finite element study. <h3>OUTCOME MEASURES</h3> The outputs analyzed in this comparison were: (a) range of motion (ROM) of L5-S1 and sacroiliac joint (SIJ) with respect to PED; (b) the maximal von Mises stresses in S1 pedicle screws; (c) the maximal von Mises stresses in either the S2 alar-iliac screws or in PFF implants in a S2 alar-iliac trajectory; (d) the maximal stresses in the posterior rods between the pedicle screws in L5 and S1 (ie, lumbosacral junction). <h3>METHODS</h3> Three instrumented T10-pelvis models were created from an intact validated model: (1) pedicle screws and rods in T10-S1, and PFF implants inserted bilaterally in a S2 alar-iliac trajectory (PFFI); (2) pedicle screws and rods in T10-S1, PFF implants inserted bilaterally in a S2 alar-iliac trajectory, and triangular implants inserted bilaterally above the PFFI in a sacro-alar-iliac trajectory (PFFI-IFSAI); and (3) pedicle screws and rods in T10-S1, PFF implants inserted bilaterally in a S2 alar-iliac trajectory, and PFF implants in a SAI trajectory stacked cephalad to those in the S2 alar-iliac position (2-PFFI). These configurations were compared against two baseline models: (1) pedicle screws and rods in T10-S1 (PED); and (2) pedicle screws and rods in T10-S1, and S2 alar-iliac screws (S2AI). All the instrumented models were used to simulate pure moments of 7.5 Nm to the upper endplate of the T10 vertebra in flexion, extension, left and right lateral bending, and left and right axial rotation. Double leg stance was simulated by fixing both acetabula of the models. <h3>RESULTS</h3> Sacropelvic fixation demonstrated a greater decrease in ROM of both L5-S1 and SIJ with respect PED. S2AI and PFFI had similar results in terms of L5-S1 and SIJ motion. PFFI-IFSAI did not affect the ROM between L5 and S1 but did reduce that of the SIJ. 2-PFFI further decreased L5-S1 motion and demonstrated a behavior similar to PFFI – IFSAI in terms of SIJ motion. S2AI fixation showed a slight increase of the stresses on S1 pedicle screws and on implants in the S2AI position with respect to PFFI. PFFI-IFSAI slightly decreased the stresses in S1 pedicle screws and on implants in the S2AI position with respect to PFFI. 2-PFFI significantly decreased the stresses on these implants (28-62 MPa for S1 pedicle screws and up to 66% for implants in the S2AI position) with respect to other configurations. In the posterior rods, the von Mises stresses were found to be highest when PFF implants were used with respect to S2AI, though all stresses were below those found in S1 pedicle screws in PED. <h3>CONCLUSIONS</h3> This study confirmed that sacropelvic fixation is able to reduce ROM at L5S1 and lower instrumentation stresses suggesting a reduced risk of pseudarthrosis at the joint and screw breakage, respectively. Moreover, outcomes suggest that PFF implants increase stability of the L5-S1 and SIJ, and reduce the risk of screw breakage. Clinical evaluation should be performed to confirm the applicability of results to patient outcomes. <h3>FDA DEVICE/DRUG STATUS</h3> iFuse Implant System (SI-BONE, Santa Clara, CA) (Approved for this indication), iFuse Bedrock Granite Implant System (SI-BONE, Santa Clara, CA) (Investigational/Not Approved).

Sacroiliac joint fusion in patients with Ehlers Danlos Syndrome: A case series

BackgroundSacroiliac joint dysfunction (SJD) is a known cause of lower back pain. SJD might be due to hypermobility in the Sacroiliac joint (SIJ) in patients with Ehlers Danlos Syndrome (EDS). Stabilization of the SIJ can be a highly successful treatment for lower back pain. No previous literature about EDS and SIJ fusion is available. The purpose of this study was to assess our mid-term results of SIJ fusion surgery in EDS patients suffering from SIJ dysfunction. MethodsA case series of patients who underwent SIJ fusion for SIJ dysfunction due to EDS between January 2012 and December 2018 were analyzed in retrospect. Patients underwent surgery and the SIJ was stabilized with triangular implants bridging the joint. Pain and functional outcomes were assessed in nine agree/disagree questions and a satisfaction performance scale. Clinical data has been extracted from the patient files and in addition, we reassessed the position of the implants on the CT scans. ResultsA total of 16 patients with EDS completed the questionnaire and were available for analysis. The mean satisfaction score is 78.1 out of 100 and seven patients reported a 100% satisfaction score. ConclusionSIJ fusion is a safe and useful procedure to reduce pain and function levels in EDS patients with lower back pain due to SIJ dysfunction.

Innovative sacropelvic fixation using iliac screws and triangular titanium implants

PurposeSacropelvic fixation is frequently used in combination with thoracolumbar instrumentation for the correction of severe spinal deformities. The purpose of this study was to explore the effects of the triangular titanium implants on the iliac screw fixation. Our hypothesis was that the use of triangular titanium implants can increase the stability of the iliac screw fixation.MethodsThree T10-pelvis instrumented models were created: pedicle screws and rods in T10-S1, and bilateral iliac screws (IL); posterior fixation and bilateral iliac screws and triangular implants inserted bilaterally in a sacro-alar-iliac trajectory (IL-Tri-SAI); posterior fixation and bilateral iliac screws and two bilateral triangular titanium implants inserted in a lateral trajectory (IL-Tri-Lat). Outputs of these models, such as hardware stresses, were compared against a model with pedicle screws and rods in T10-S1 (PED).ResultsSacropelvic fixation decreased the L5-S1 motion by 75–90%. The motion of the SIJ was reduced by 55–80% after iliac fixation; the addition of triangular titanium implants further reduced it. IL, IL-Tri-SAI and IL-Tri-Lat demonstrated lower S1 pedicle stresses with respect to PED. Triangular implants had a protective effect on the iliac screw stresses.ConclusionSacropelvic fixation decreased L5-S1 range of motion suggesting increased stability of the joint. The combination of triangular titanium implants and iliac screws reduced the residual flexibility of the sacroiliac joint, and resulted in a protective effect on the S1 pedicle screws and iliac screws themselves. Clinical studies may be performed to demonstrate applicability of these FEA results to patient outcomes.

Three-Year Clinical Outcomes after Minimally Invasive Sacroiliac Joint Arthrodesis Using Triangular Implants in Japan: A Pilot Study of Five Cases.

Introduction Sacroiliac joint (SIJ) arthrodesis using a minimally invasive technique, particularly the triangular implant system, is performed in patients with SIJ dysfunction in the United States and Europe. We report three-year clinical outcomes of the first minimally invasive SIJ arthrodesis procedures using the implants performed in Japan. Methods Five patients (one man and four women; age: 56.4±16.9 years) with SIJ pain who underwent SIJ arthrodesis using a triangular implant system in 2017 were included. In addition to operation time and blood loss, pain intensity (visual analog scale [VAS]) and functional impairment (Oswestry disability index [ODI]) were assessed preoperatively and at a 36-month follow-up. Implant loosening and osseous bridging across the joint were evaluated using computed tomography images, and patients' satisfaction with the surgery was also assessed at 12 and 36 months. Results The surgical time was 67.7±13.1 minutes, and blood loss was 7.4±6.9 mL. The mean VAS value improved significantly from 88.0±8.4 mm to 33.6±31.9 mm at 3 months and was maintained at 46.4±30.9 mm at 36 months (P<0.05). The mean ODI improved significantly from 76.4%±3.8% to 46.2%±21.9% at 6 months postoperatively (P<0.05) but had no significant improvements thereafter: 46.94±23.7% (12 months) and 66.4±8.6% (36 months). Three of five patients presented with at least one implant loosening on the sacrum side. No patient had osseous bridging across the joint. A total of 80% (4/5) of patients reported satisfaction with the surgery at 12 months and 60% (3/5) at 36 months. Conclusions The mean VAS value and ODI significantly improved until 6 months after the surgery. However, the mean ODI was reaggravated at 36 months after the surgery. Osseous bridging across the joint was not observed in all patients. We should carefully keep an eye on further long-term results to evaluate the implant.

Instrumentation of the sacroiliac joint with cylindrical threaded implants: A detailed finite element study of patient characteristics affecting fixation performance.

The sacroiliac joint (SIJ) is a known pain generator that, in severe cases, may require surgical fixation to reduce intra-articular displacements and allow for arthrodesis. The objective of this computational study was to analyze how the number of implants affected SIJ stabilization with patient-specific characteristics such as the pelvic geometry and bone quality. Detailed finite element models were developed to account for three pelvises of differing anatomy. Each model was tested with a normal and low bone density (LD) under two types of loading: compression only and compression with flexion and extension moments. These models were instrumented with one to three cylindrical, threaded and fenestrated implants through a posterior oblique trajectory, requiring less muscle dissection than the more common lateral trajectory used with triangular implants. Compared with the noninstrumented pelvis, the change in range of motion (ROM) and stress distribution were used to characterize joint stabilization. Noninstrumented mobility ranged from 0.86 to 2.55 mm and from 1.37° to 6.11°. Across patient-specific characteristics, the ROM reduction with one implant varied from3% to 21% for vertical and 15% to 47% for angular displacements. With two implants, the ROM reduction ranged from 12% to 41% for vertical and from 28% to 61% for angular displacements. Three implants, however, did not further improve the joint stability (14% to 42% for vertical and 32% to 63% for angular displacements). With respect to patient characteristics, an LD led to a decreased stabilization and a higher volume of stressed bone (>75% of yield stress). A better understanding of how patient characteristics affect the implant performance could help improve surgical planning of sacroiliac arthrodesis.

Minimally Invasive Sacroiliac Joint Fusion with Triangular Titanium Implants: Cost-Utility Analysis from NHS Perspective.

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.Electronic supplementary materialThe online version of this article (10.1007/s41669-020-00236-5) contains supplementary material, which is available to authorized users.

The use of triangular implants to enhance sacropelvic fixation: a finite element investigation

Background contextLong thoracolumbar fixation and fusion have become a consolidated treatment for severe spinal disorders. Concomitant sacropelvic fixation with S2 alar-iliac (S2AI) screws is frequently performed to limit instrumentation failure and pseudarthrosis at the lumbosacral junction. PurposeThis study explored the use of triangular titanium implants in different configurations in which the implants supplemented standard sacropelvic fixation with S2AI screws in order to further increase the stability of S2AI fixation. Study designFinite element study. MethodsFour T10-pelvis instrumented models were built: pedicle screws and rods in T10–S1 (PED); pedicle screws and rods in T10–S1, and bilateral S2 alar-iliac screws (S2AI); pedicle screws and rods in T10–S1, bilateral S2AI screws, and triangular implants inserted bilaterally in a sacral alar-iliac trajectory (Tri-SAI); pedicle screws and rods in T10–S1, bilateral S2AI screws and two bilateral triangular titanium implants inserted in a lateral trajectory (Tri-Lat). The models were tested under pure moments of 7.5 Nm in flexion-extension, lateral bending and axial rotation. RESULTSSIJ motion was reduced by 50% to 66% after S2AI fixation; the addition of triangular titanium implants in either a SAI or a lateral trajectory further reduced it. S2AI, Tri-SAI, and Tri-Lat resulted in significantly lower stresses in S1 pedicle screws when compared to PED. Triangular implants had a protective effect on the maximal stresses in S2AI screws, especially when placed in the SAI trajectory. Sacropelvic fixation did not have any protective effect on the posterior rods. ConclusionsSupplementing S2AI screws with triangular implants had a protective effect on the S2AI screws themselves, as well as the S1 pedicle screws, in the tested model. Clinical significanceTriangular implants can substantially reduce the residual flexibility of the SIJ with respect to S2AI fixation alone, suggesting a possible role in patients needing reinforced fixation. In vivo investigation is needed to determine if these in vitro effects translate into clinically important differences.

Patients' satisfaction and outcomes of minimally invasive sacroiliac joint fusion at a tertiary care center

Objectives: Sacroiliac (SI) joint dysfunction usually relates to SI joint pain that results from unusual patterns of motion within the joint, whether excessive or insufficient. SI joint pain is a frequent reason for axial back pain, which is suffered by around 30% of the population. This retrospective study intends to examine the safety and efficiency of minimally invasive (MI) SI joint fusion that employs triangular implants for individuals where conservative management has not succeeded. Methods: An observational study with eight patients on whom one surgeon performed ten consecutive SI joint fusion operations; all patients have completed their 12-month review. The study has examined medical records for demographic details, perioperative data, pain scores, satisfaction levels, safety procedures, complications, and fusion rates 1 year after the operation. Results: At the time of surgery, the patients had a mean age of 37.87 years (ranging from 17 to 58). All but one patient were female. Between 2016 and 2019, 10 SI joints in these eight patients underwent fusion. Four patients had left side fusion, two had right side fusion, and two had bilateral SI joint fusion. Pain scores were reduced considerably, with a mean drop of 6. On the 12-month follow-up, with only one joint had not undergone satisfactory fusion. Conclusions: This study demonstrated that MISI joint fusion employing triangular implants is both safe and effective for treating this particular cohort of patients.

Biomechanics of sacropelvic fixation: a comprehensive finite element comparison of three techniques.

Sacropelvic fixation is frequently used in combination with thoracolumbar instrumentation for complex deformity correction and is commonly associated with pseudoarthrosis, implant failure and loosening. This study compared pedicle screw fixation (PED) with three different sacropelvic fixation techniques, namely iliac screws (IL), S2 alar-iliac screws (S2AI) and laterally placed triangular titanium implants (SI), all in combination with lumbosacral instrumentation, accounting for implant micromotion. Existing finite element models of pelvis-L5 of three patients including lumbopelvic instrumentation were utilized. Moments of 7.5 Nm in the three directions combined with a 500N compressive load were simulated. Measured metrics included flexibility, instrumentation stresses and bone-implant interface loads. Fixation effectively reduced the sacroiliac flexibility. Compared to PED, IL and S2AI induced a reduction in peak stresses in the S1 pedicle screws. Rod stresses were mostly unaffected by S2AI and SI, but IL demonstrated a stress increase. In comparison with a previous work depicting full osteointegration, SI was found to have similar instrumentation stresses as those due to PED. Fixation with triangular implants did not result in stress increase on the lumbosacral instrumentation, likely due to the lack of connection with the posterior rods. IL and S2AI had a mild protective effect on S1 pedicle screws in terms of stresses and bone-implant loads. IL resulted in an increase in the rod stresses. A comparison between this study and previous work incorporating full osteointegration demonstrates how these results may be applied clinically to better understand the effects of different treatments on patient outcomes. These slides can be retrieved under Electronic Supplementary Material.

Evaluation of iliac screw, S2 alar-iliac screw and laterally placed triangular titanium implants for sacropelvic fixation in combination with posterior lumbar instrumentation: a finite element study

This study aimed to implement laterally placed triangular titanium implants as a technique of sacropelvic fixation in long posterior lumbar instrumentation and to characterize the effects of iliac screws, S2 alar-iliac screws and of triangular implants on rod and S1 pedicle screw stresses. Four female models of the lumbopelvic spine were created. For each of them, five finite element models replicating the following configurations were generated: intact, posterior fixation with pedicle screws to S1 (PED), with PED and iliac screws (IL), with PED and S2 alar-iliac (S2AI) screws, and with PED and bilateral triangular titanium implants (SI). Simulations were conducted in compression, flexion-extension, lateral bending and axial rotation. Rod stresses in the L5-S1 segment as well as in the S1 pedicle screws were compared. One anatomical model was not simulated due to dysmorphia of the sacroiliac joints. PED resulted in the highest implant stresses. Values up to 337MPa in lateral bending were noted, which were more than double than the other configurations. When compared with IL, S2AI and SI resulted in lower stresses in both screws and rods (on average 33% and 41% for S2AI and 17% and 50% for SI). Implant stresses after S2AI and SI fixations were lower than those attributable to IL. Therefore, pedicle screws and rods may have a lower risk of mechanical failure when coupled with sacropelvic fixation via S2AI or triangular titanium implants, although the risk of clinical loosening remains an area of further investigation. These slides can be retrieved under Electronic Supplementary Material.

Sacroiliac joint stability: Finite element analysis of implant number, orientation, and superior implant length.

AIMTo analyze how various implants placement variables affect sacroiliac (SI) joint range of motion.METHODSAn experimentally validated finite element model of the lumbar spine and pelvis was used to simulate a fusion of the SI joint using various placement configurations of triangular implants (iFuse Implant System®). Placement configurations were varied by changing implant orientation, superior implant length, and number of implants. The range of motion of the SI joint was calculated using a constant moment of 10 N-m with a follower load of 400 N. The changes in motion were compared between the treatment groups to assess how the different variables affected the overall motion of the SI joint.RESULTSTransarticular placement of 3 implants with superior implants that end in the middle of the sacrum resulted in the greatest reduction in range of motion (flexion/extension = 73%, lateral bending = 42%, axial rotation = 72%). The range of motions of the SI joints were reduced with use of transarticular orientation (9%-18%) when compared with an inline orientation. The use of a superior implant that ended mid-sacrum resulted in median reductions of (8%-14%) when compared with a superior implant that ended in the middle of the ala. Reducing the number of implants, resulted in increased SI joint range of motions for the 1 and 2 implant models of 29%-133% and 2%-39%, respectively, when compared with the 3 implant model.CONCLUSIONUsing a validated finite element model we demonstrated that placement of 3 implants across the SI joint using a transarticular orientation with superior implant reaching the sacral midline resulted in the most stable construct. Additional clinical studies may be required to confirm these results.

Revision of Minimally Invasive Sacroiliac Joint Fixation: Technical Considerations and Case Studies Using Decortication and Threaded Implant Fixation.

Sacroiliac joint (SIJ) disease is increasingly recognized as a common source of low back pain. Arthrodesis of the SIJ has been shown to be clinically effective for this condition. In the last decade, minimally invasive (MI) SIJ fusion procedures have been developed to achieve the clinical effectiveness of open fusion procedures, with lower operative morbidity and faster recovery. However, SIJ fusion patients occasionally present with symptomatic nonunions necessitating revision. Four patients who previously underwent MI SIJ arthrodesis returned with complaints of SIJ related pain confirmed by examination. Radiographic assessment showed lucency after fixation with triangular titanium interference implants. Loose implants were removed, and the patients were revised with a different MI SIJ fusion system that utilizes decortication, placement of autograft and graft extender, and fixation with cannulated threaded implants. The trajectory of the revision implants was in a more ventral-to-dorsal and caudal-to-cranial trajectory to place the implants perpendicularly through the articular portion of the SIJ. The triangular implants typically exhibited haloing lucency on radiographs and CT scans, and most were easily removed using the manufacturer's instrumentation; only one implant was left in place as it was well-fixed. The removed implants exhibited little or no bony ongrowth. Decortication of the SIJ was performed, followed by placement of local autograft and fixation with 12.5 mm or 14.5mm diameter implants, as required. A more ventral-todorsal and caudal-to-cranial trajectory was established for the revision implants through the center of the articular region of the joint in order to maximize implant purchase in residual bone stock and achieve bony fusion through the articular portion of the SIJ. By six to twelve months post-revision, the presenting symptoms were successfully resolved in all patients. Patients demonstrating symptomatic pseudoarthrosis after SIJ fixation surgery can be successfully revised with decortication, grafting and fixation with threaded implants utilizing MI surgical techniques. Implant trajectory is an important consideration for primary or revision MIS SIJ fusion. Studies with longer-term follow-up of both primary and revision procedures are needed to further understand fusion rates for both primary and revision procedures utilizing both triangular and threaded implant systems.

Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants.

Minimally invasive surgical fusion of the sacroiliac (SI) joint using machined solid triangular titanium plasma spray (TPS) coated implants has demonstrated positive clinical outcomes in SI joint pain patients. Additive manufactured (AM), i.e. 3D-printed, fenestrated triangular titanium implants with porous surfaces and bioactive agents, such as nanocrystalline hydroxyapatite (HA) or autograft, may further optimize bony fixation and subsequent biomechanical stability. A bilateral ovine distal femoral defect model was used to evaluate the cancellous bone-implant interfaces of TPS-coated and AM implants. Four implant groups (n=6/group/time-point) were included: 1)TPS-coated, 2)AM, 3)AM+HA, and 4)AM+Autograft. The bone-implant interfaces of 6- and 12-week specimens were investigated via radiographic, biomechanical, and histomorphometric methods. Imaging showed peri-implant bone formation around all implants. Push-out testing demonstrated forces greater than 2500 N, with no significant differences among groups. While TPS implants failed primarily at the bone-implant interface, AM groups failed within bone ~2-3mm away from implant surfaces. All implants exhibited bone ongrowth, with no significant differences among groups. AM implants had significantly more bone ingrowth into their porous surfaces than TPS-coated implants (p<0.0001). Of the three AM groups, AM+Auto implants had the greatest bone ingrowth into the porous surface and through their core (p<0.002). Both TPS and AM implants exhibited substantial bone ongrowth and ingrowth, with additional bone through growth into the AM implants' core. Overall, AM implants experienced significantly more bone infiltration compared to TPS implants. While HA-coating did not further enhance results, the addition of autograft fostered greater osteointegration for AM implants. Additive manufactured implants with a porous surface provide a highly interconnected porous surface that has comparatively greater surface area for bony integration. Results suggest this may prove advantageous toward promoting enhanced biomechanical stability compared to TPS-coated implants for SI joint fusion procedures.

Sacroiliac Joint Fusion Minimally Affects Adjacent Lumbar Segment Motion: A Finite Element Study

Adjacent segment disease is a recognized consequence of fusion in the spinal column. Fusion of the sacroiliac joint is an effective method of pain reduction. Although effective, the consequences of sacroiliac joint fusion and the potential for adjacent segment disease for the adjacent lumbar spinal levels is unknown. The objective of this study was to quantify the change in range of motion of the sacroiliac joint and the adjacent lumbar spinal motion segments due to sacroiliac joint fusion and compare these changes to previous literature to assess the potential for adjacent segment disease in the lumbar spine. An experimentally validated finite element model of the lumbar spine and pelvis was used to simulate a fusion of the sacroiliac joint using three laterally placed triangular implants (iFuse Implant System, SI-BONE, Inc., San Jose, CA). The range of motion of the sacroiliac joint and the adjacent lumbar spinal motion segments were calculated using a hybrid loading protocol and compared with the intact range of motion in flexion, extension, lateral bending, and axial rotation. The range of motions of the treated sacroiliac joints were reduced in flexion, extension, lateral bending, and axial rotation, by 56.6%, 59.5%, 27.8%, and 53.3%, respectively when compared with the intact condition. The stiffening of the sacroiliac joint resulted in increases at the adjacent lumbar motion segment (L5-S1) for flexion, extension, lateral bending, and axial rotation, of 3.0%, 3.7%, 1.1%, and 4.6%, respectively. Fusion of the sacroiliac joint resulted in substantial (> 50%) reductions in flexion, extension, and axial rotation of the sacroiliac joint with minimal (< 5%) increases in range of motion in the lumbar spine. Although the predicted increases in lumbar range of motion are minimal after sacroiliac joint fusion, the long-term clinical results remain to be investigated.

One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis.

BackgroundSacroiliac joint (SI) pain is an often-overlooked cause of lower-back pain, due in part to a lack of specific findings on radiographs and a symptom profile similar to other back-related disorders. A minimally invasive surgical (MIS) approach to SI joint fusion using a series of triangular, titanium plasma spray-coated implants has shown favorable outcomes in patients with SI joint pain refractory to conservative care. The aim of this study was to provide a multicenter experience of MIS SI joint fusion using a patient-level analysis.Patients and methodsWe report a patient-level analysis from 144 patients with a mean of 16 months postoperative follow-up. Demographic information, perioperative measures, complications, and clinical outcomes using a visual analog scale for pain were collected prospectively. Random-effects regression models were used to account for intersite variability.ResultsThe mean age was 58 years, 71% of patients were female, and 62% had a history of lumbar spinal fusion. Mean (95% confidence interval [CI]) operative time was 73 minutes (25.4–118), blood loss was minimal, and hospital stay was 0.8 days (0.1–1.5). At follow-up, mean (95% CI) visual analog scale pain scores improved by 6.1 points (5.7–6.6). Substantial clinical benefit, defined as a decrease in pain by >2.5 points or a score of 3.5 or less, was achieved in 91.9% of patients (95% CI 83.9%–96.1%), and 96% (95% CI 86.3%–98.8%) of patients indicated they would have the same surgery again.ConclusionWhen conservative measures fail to relieve symptoms resulting from degeneration or disruption of the SI joint, MIS SI joint fusion using a series of triangular, porous, titanium plasma spray-coated implants is a safe and effective treatment option.