Evaluation of a minimally invasive procedure for sacroiliac joint fusion – an in vitro biomechanical analysis of initial and cycled properties (original) (raw)
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Medical Devices: Evidence and Research, 2014
Introduction: Sacroiliac (SI) joint pain has become a recognized factor in low back pain. The purpose of this study was to investigate the effect of a minimally invasive surgical SI joint fusion procedure on the in vitro biomechanics of the SI joint before and after cyclic loading. Methods: Seven cadaveric specimens were tested under the following conditions: intact, posterior ligaments (PL) and pubic symphysis (PS) cut, treated (three implants placed), and after 5,000 cycles of flexion-extension. The range of motion (ROM) in flexion-extension, lateral bending, and axial rotation was determined with an applied 7.5 N ⋅ m moment using an optoelectronic system. Results for each ROM were compared using a repeated measures analysis of variance (ANOVA) with a Holm-Šidák post-hoc test. Results: Placement of three fusion devices decreased the flexion-extension ROM. Lateral bending and axial rotation were not significantly altered. All PL/PS cut and post-cyclic ROMs were larger than in the intact condition. The 5,000 cycles of flexion-extension did not lead to a significant increase in any ROMs. Discussion: In the current model, placement of three 7.0 mm iFuse Implants significantly decreased the flexion-extension ROM. Joint ROM was not increased by 5,000 flexion-extension cycles.
Biomechanical Stability of Primary and Revision Sacroiliac Joint Fusion Devices: A Cadaveric Study
Global Spine Journal, 2020
Study Design:An in vitro biomechanics study.Objective:To evaluate the efficacy of triangular titanium implants in providing mechanical stabilization to a sacroiliac joint with primary and revision sized implants.Methods:Ten lumbopelvic cadaveric specimens were tested in 4 stages: intact, pubic symphysis sectioned, primary, and simulated revision. Primary treatment was performed using 3 laterally placed triangular titanium implants. To simulate revision conditions before and after bone ingrowth and ongrowth on the implants, 7.5-mm and 10.75-mm implants were randomly assigned to one side of each specimen during the simulated revision stage. A 6 degrees of freedom spinal loading frame was used to load specimens in 4 directions: flexion extension, lateral bending, axial torsion, and axial compression. Biomechanical evaluation was based on measures of sacroiliac joint rotational and translational motion.Results:Both primary and revision implants showed the ability to reduce translational...
In Vitro Biomechanical Evaluation of a Novel, Minimally Invasive, Sacroiliac Joint Fixation Device
International journal of spine surgery, 2018
Sacroiliac (SI) joint pathology may result in low-back pain, which causes substantial disability. Treatment failure with operative management of SI pain may be related to incomplete fusion of the joint and to fixation failure. The objective of this study was to evaluate the initial biomechanical stability of SI joint fixation with a novel implantable device in an in vitro human cadaveric model. The right and left sides of 3 cadaveric L4-pelvis specimens were tested (1) intact, (2) destabilized, and (3) instrumented with an implantable SI joint fixation device using a simulated single-stance load condition. Right-leg and left-leg stance data were grouped together for a sample size of 6, and angular range of motion (ROM) was determined during application of flexion-extension, lateral bending, and axial rotation bending moments to a limit of 7.5 Nm. Following intact testing, destabilization by severing the posterior SI joint capsule and ligaments and the pubic symphysis reliably produc...
Patient Reported Outcomes from Sacroiliac Joint Fusion
Asian Spine Journal
Study DesignRetrospective, case series.PurposeThe purpose of this study is to determine morbidity, complications, and patient reported outcomes from minimally invasive sacroiliac joint (SIJ) fusion.Overview of LiteratureLumbar back pain emanating from the SIJ can be surgically treated via a percutaneous approach in the appropriately selected patient with minimal morbidity and acceptable functional outcomes.MethodsPatients diagnosed by >2 physical examination maneuvers and subjective relief from a computed tomography–guided lidocaine-bupivacaine-steroid injection underwent SIJ fusion after failing conservative management with a combination of oral anti-inflammatory medications, physical therapy, and pelvic belt stabilization. Perioperative data collected include estimated blood loss (EBL) and operative time. Oswestry disability index, 12-item short form health survey (SF-12), visual analogue score, and functional status were analyzed. All complications were noted.ResultsThe study ...
Journal of Neurosurgery: Spine, 2021
OBJECTIVE S2-alar-iliac (S2AI) screw fixation effectively ensures stability and enhances fusion in long-segment constructs. Nevertheless, pelvic fixation is associated with a high rate of mechanical failure. Because of the transarticular nature of the S2AI screw, adding a second point of fixation may provide additional stability and attenuate strains. The objective of the study was to evaluate changes in stability and strain with the integration of a sacroiliac (SI) joint fusion device, implanted through a novel posterior SI approach, supplemental to posterior long-segment fusion. METHODS L1-pelvis human cadaveric specimens underwent pure moment (7.5 Nm) and compression (400 N) tests in the following conditions: 1) intact, 2) L2–S1 pedicle screw and rod fixation with L5–S1 interbody fusion, 3) added S2AI screws, and 4) added bilateral SI joint fixation (SIJF). The range of motion (ROM), rod strain, and screw bending moments (S1 and S2AI) were analyzed. RESULTS S2AI fixation decrease...
Journal of Orthopaedic Surgery and Research
Background For 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. Methods SIJ 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 event...
International journal of spine surgery, 2016
Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvem...
Sacroiliac Joint Fusion Minimally Affects Adjacent Lumbar Segment Motion: A Finite Element Study
The International Journal of Spine Surgery, 2015
Background 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. Methods 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. Results 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. Conclusions 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.
Biomechanical evaluation of sacroiliac joint fixation with decortication
The spine journal : official journal of the North American Spine Society, 2018
Fusion typically consists of joint preparation, grafting, and rigid fixation. Fusion has been successfully used to treat symptomatic disruptions of the sacroiliac joint (SIJ) and degenerative sacroiliitis using purpose-specific, threaded implants. The biomechanical performance of these systems is important but has not been studied. The objective of this study was to compare two techniques for placing primary (12.5 mm) and secondary (8.5 mm) implants across the SIJ. This is a human cadaveric biomechanical study of SIJ fixation. Pure-moment testing was performed on 14 human SIJs in flexion-extension (FE), lateral bending (LB), and axial rotation (AR) with motion measured across the SIJ. Specimens were tested intact, after destabilization (cutting the pubic symphysis), after decortication and implantation of a primary 12.5-mm implant at S1 plus an 8.5-mm secondary implant at either S1 (S1-S1, n=8) or S2 (S1-S2, n=8), after cyclic loading, and after removal of the secondary implant. Ran...