Joint Fusion

Methods: The investigators will perform a pilot prospective randomized double-blinded placebo-controlled trial of 60 patients undergoing major elective reconstructive spinal surgery to investigate the effect of a postoperative lidocaine infusion on the incidence and severity of postoperative delirium. Major spine surgery is defined as posterior spine fusions \>3 levels of instrumentation and fusion, which allows standardization of the level of surgical insult and postoperative analgesic requirements. The intraoperative anesthetic regimen will be standardized to consist of total intravenous anesthesia using sevoflurane, propofol, lidocaine and magnesium (institutional protocol), and fentanyl with boluses allowed per provider discretion. Patient recruitment, inclusion and exclusion criteria: All surgeons will be contacted before the start of the study to obtain their consent to allow their patients to be studied. The research team has successfully completed multiple National Institutes of Health (NIH) funded cohort and clinical trials at our institution with no surgeon refusing to participate. Eligible patients will be screened from the operating room roster to determine their eligibility. Patients will be contacted by phone or in person for preoperative evaluation. Please see the other section for inclusion and exclusion criteria. Sample Size Calculation: The recruitment will be consecutive patients meeting inclusion criteria. Reductions in opioid consumption by \~25% using intravenous lidocaine infusions have been shown to decrease opioid related side effects, but there is essentially no data linking a specific degree of opioid reduction to effects on delirium (46, 47). The most comparable published study to the investigators' proposal is work done by Kaba (2009) studying a lidocaine infusion for abdominal surgery where the average opioid reduction was \~50% (24mg +/-16.3 of piritramide in the placebo vs. 10.33mg +/- 10.33 in the treatment group). Assuming similar reduction in opioids of 50% and similar variance, the proposed sample size, 60 (30 per group), provides a power of 0.8 (alpha = 0.05) to detect a 25% decrease in the use of postoperative opioids. Randomization: Patients will be randomized utilizing block randomization by a random number generator into either placebo or treatment groups by the research pharmacist. The randomization scheme will be blinded to the researchers and patients. Anesthetic Management: The anesthetic management will be standardized. All patients will receive a general anesthetic to consisting of 50% oxygen and total intravenous anesthetics consisting of infusions of propofol (60-150 mcg/kg/min), lidocaine (1 mg/kg bolus, then 1.5 mg/kg/hr infusion), magnesium (30 mg/kg bolus, then 6 mg/kg/hr infusion), fentanyl (1 mcg/kg bolus, then 1 mcg/kg/hr infusion, prn boluses), and 0.3 Minimum Alveolar Concentration (MAC) of sevoflurane. Anesthesiologists will be requested to maintain the patient's arterial blood pressure to within 20% of their preoperative baseline using vasoactive agents. Patients will receive mechanical ventilation to maintain normocarbia. Intraoperative warming devices will be used to keep body temperature between 36-37˚C. Oxygen saturation will be maintained \>95%. Muscle relaxants will be used during tracheal intubation and only as clinically indicated at other time periods. All patients will be continuously monitored before the induction of anesthesia and during surgery with SEDline Brain Function Monitor (Masimo, Inc., Irvine CA), a standard monitor at our institution. Anesthesiologists will be asked to minimize electroencephalogram (EEG) burst suppression by adjusting the doses of anesthetic drugs since prior studies have suggested a relationship between burst suppression and postoperative delirium (48, 49). Postoperatively, but before discharge from the post anesthetic care unit or upon arrival to the intensive care unit, patients will be randomized to receive either placebo or a lidocaine infusion. Please see the other sections for a list of primary and secondary outcomes. Briefly the primary outcome is the effect of an intravenous lidocaine infusion on the incidence and severity of postoperative delirium. Secondary outcomes include intravenous lidocaine safety and tolerability, the effect of a lidocaine infusion on opioid usage, pain scores, analgesic satisfaction, opioid related side effects, and functional benefits. Statistical Analysis The investigators will use descriptive statistics to summarize the characteristics of the study population by treatment groups. The investigators will use an intention to treat paradigm in assessing the effect of the intervention on the outcomes of interest. Aim 1: To evaluate the safety of a continuous infusion of lidocaine in the first two days after surgery. The investigators will compare the proportion of patients that experienced at least one of the adverse events between the two groups using either the Fisher Exact Test or Chi Square Test as appropriate. Aim 2: To compare postoperative pain, and opioid usage between patients who receive placebo infusions vs. lidocaine infusions. All opioid doses will be converted to oral morphine equivalents. Specifically, hydromorphone and fentanyl doses will be converted to morphine equivalents using the conversion formula: 1.5 mg of hydromorphone = 10 mg of morphine equivalents, 0.1mg of fentanyl = 10 mg of morphine equivalents (56,57). The investigators will compare the average pain scores and opioids doses between the two treatment groups using two-sample t-tests or Mann-Whitney nonparametric tests if the data are not normally distributed. Aim 3: To compare the incidence of postoperative delirium between patients who receive placebo infusions vs. lidocaine infusions. Chi-square tests will be conducted to determine the association between lidocaine infusions and incident delirium. Aim 4: To compare the functional recovery of patients between patients who receive placebo infusions vs. lidocaine infusions. The investigators will compare the results of the 36-Item Short Form Health Survey (SF-36), Oswestry Disability Index (ODI), time to discharge, and ability to participate in physical therapy, using the two sample t-test or Mann-Whitney nonparametric test for continuous outcomes, and Fisher exact Test or Chi Square test for binary outcomes. Relevant biologic variables - All analyzes will include sex and ethnicity as covariates. Missing Data - Sensitivity Analyses to Assess the Effects of Missing Data: The investigators will use model-based methods, such as Heckman and Predicted mean matching models to determine the effect of missing observations for each of these reasons on the estimates. The investigators will track the number of missing responses for delirium, and upwardly adjust the sample size accordingly. This strategy may result in having to recruit and follow an additional subject per week in the second year of data collection, which is feasible. The investigators will conduct sensitivity analyses to determine the effect of missing data on the outcomes of interest.

This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use. This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery.

The application of traditional SSEPs and tcMEPs to lumbar nerve root monitoring during TLIF surgery is both challenging and problematic. When applied to lumbar nerve root monitoring, SSEPs and tcMEPs unfortunately suffer in specificity, sensitivity, or both. A surgeon thus cannot confidently rely on these techniques to monitor nerve root function and must guess the likelihood of dysfunction. Spontaneous EMG (sEMG) is also used to monitor nerve root activity. While sEMG is an excellent indicator of spinal nerve root manipulation, it is a poor diagnostic indicator of dysfunction. 90-95% of sEMG alerts are not associated with dysfunction yielding a high false positive rate and poor specificity, and postoperative deficits are often not associated with sEMG alerts yielding many false negatives and poor sensitivity. The primary utility of sEMG is to use as an indicator of manipulation, which prompts the acquisition of tcMEPs to assess function. There is a clear need to take the guesswork out of monitoring the functional status of nerve roots at risk during lumbar decompressions and select interbody fusions. During TLIFs, the exiting nerve root is at risk as it courses obliquely across disc space encroaching on the surgical corridor. Standardly, a hand-held retractor is used to retract and protect the nerve root during disc space preparation, implant insertion or even simple decompression. This maneuver and retraction place a particular nerve root at risk, but again, traditional SSEP and tcMEPs are not ideal for monitoring that risk. The EARP Nerve Cuff Electrode (Retropsoas Technologies) is a novel, Class II, device that is 510(k) cleared by FDA. It conducts electrical signals as a component of intraoperative neuromonitoring, is used with commercially available neuromonitoring systems, and does not stimulate or record the signal itself. The standard connectors at the proximal end interface with the neuromonitoring equipment. The distal nerve cuff electrode partially encircles and contacts the target nerve root. It uses a bipolar configuration to limit current spread. It is available in several inner diameters to accommodate variability in patient nerve root size anatomy. The EARP Retractor is a Class I device used with a commercially available Retractor system and is only used as an additional 4th blade. In TLIF surgery, the exiting nerve must be retracted to allow for sufficient access to the intervertebral disc space. The retraction is applied at the medial portion of the nerve root. The application of this retraction may produce activity in the nerve root and/or conduction changes in the nerve root due to temporary manipulation, compression, or ischemia related to the retraction.1 The objective of the study is to demonstrate the ability to safely monitor lumbar nerve root activity and function during retraction using an Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and an EARP Retractor system during a standard Transforaminal Lumbar Interbody Fusion (TLIF), with improved specificity and sensitivity over traditional monitoring techniques.

This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion surgery. Seventy-two women with low bone mass who are scheduled to undergo spinal fusion surgery will be randomized 2:1 in a blinded fashion to receive either 80 mcg of abaloparatide subcutaneously (SC) every day or an identical-appearing placebo SC for 6 months. In addition, as Tymlos is now approved for treatment in men, the investigators will enroll 24 men aged 55 and over who will treat in an open-label design. Their responses to teriparatide will be compared to those of untreated men in an ongoing observational study, as well as to the postmenopausal women. This study has 3 objectives: 1. In this pilot study the investigators will evaluate surgical outcomes at one year and the primary outcome will be fusion based on CT exam with categories of Fusion/ Indeterminate/ Not fused and this will be compared between groups receiving 6 months of abaloparatide vs. placebo. Secondary outcomes for surgical success will be evidence of pedicle screw loosening, adjacent segment fracture and proximal junctional kyphosis. This data will be used to determine effect sizes and variance to power the next larger clinical trial. 2. To determine if abaloparatide/Tymlos versus placebo leads to a faster reduction in pain as assessed by both the Numeric Rating Scale (NRS) and the Oswestry Disability Index (ODI) for low back pain at 6 months. 3. As an exploratory proof of concept objective the investigators will determine if abaloparatide/Tymlos versus placebo results in greater fusion bone mass volume (FBMV) as a marker of bone union at 6 months and 1 year to see whether at one year post lumbar spinal fusion surgery, greater FBMV is associated with improved spinal surgery outcomes including: enhanced bone union, reduced pedicle screw loosening, adjacent segment fracture and proximal junctional kyphosis. This would serve as evidence that FBMV can be used as an early validated marker of fusion surgery success. All analyses will be two-sided and the alpha level will be set at 0.05. FBMV, pain and function will be compared by drug (Abaloparatide vs. placebo) at 6 months. Compliance will be considered as taking 80% of the study drug. For the primary analysis the investigators will evaluate bone union and reduced pedicle screw loosening, adjacent segment fracture, and proximal junctional kyphosis as dichotomous variables at 12 months using logistic regression and comparing the placebo group to the abaloparatide group. The investigators will also evaluate FBMV as a continuous variable and evaluate differences in this outcome between abaloparatide and placebo groups at 6 months as an exploratory outcome variable. The investigators will determine if FBMV differs in those with or without markers of surgical success for validity of FBMV, regardless of prior treatment group. In addition, these data will be used to determine effect sizes and variance to power the next larger clinical trial. The investigators will evaluate NRS and ODI score by using repeated measures of these variables over time by treatment group and evaluate NRS at 6 months in the placebo versus abaloparatide group. Comorbidity, age, prior fracture, prior use of bisphosphonates and other covariates will be evaluated, via multivariable regression, as to whether they lead to a change in the estimate of effect in order to be considered for inclusion in the models. If abaloparatide can improve outcomes following lumbar spine fusion surgery, this pilot study could lead to the requisite two year trial that may have an impact on the treatment of fusion surgery patients.

The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization. Regional anesthesia techniques, mainly epidural analgesia and, more recently, paravertebral blocks, became crucial parts of the multimodal analgesia (MMA) regimen after introducing ultrasound (US) in the regional anesthesia practice. Erector spinae plane (ESP) block and mid-transverse to pleura (MTP) block are the latest developments in postoperative pain therapy.

Detailed Description: This prospective, randomized, controlled trial will test whether adding Aprepitant to standard multimodal therapy regimen can further reduce the incidence and severity of post-operative nausea and vomiting (PONV) in children undergoing posterior spinal instrumentation and fusion. The primary outcome of the study will be anti-nausea rescue medication administration post-surgery, with secondary outcomes being the first instance of post-surgery anti-nausea rescue medication administration, emesis, headache, flatus, bowel movement, and sensation of itch; incidence of treatment-emergent adverse events; and worst nausea and pain scores post-surgery .

Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years. Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.

Cervical degenerative disc disease (CDDD) is the degeneration of a cervical intervertebral disc and/or the adjoining vertebral bodies, resulting in clinical symptoms of cervical radiculopathy, myelopathy, myeloradiculopathy, and axial pain. The incidence of degenerative pathologies is significantly increasing as the population of elderly is rising. Currently, generalized spinal disc degeneration occurs in more than 90% of adults past the 5th decade of life.This age group now represents 32.8% of the population in Europe and is projected to reach 40.6% by 2050. In the next 20 years a significant increase in anterior cervical decompression surgeries is predicted in those aged 45-54, mainly affecting the working population. Complaints of radiculopathy and/or myelopathy lead to restrictions in daily life and loss of professional capability, resulting in absenteeism. Societal healthcare costs are therefore significantly affected by CDDD. The healthcare costs are driven up further when patients require surgical treatment, in combination with associated hospitalization and rehabilitation. To date, no consensus exists on which anterior surgical technique is more cost-effective to treat CDDD with radiculopathy and/or myelopathy. One of the most common procedures for treating patients with single- or multilevel CDDD is anterior cervical discectomy with fusion (ACDF). ACDF results in fusion in 95-100%. The primary goal of ACD(F) is the relief of symptoms of radiculopathy and/or myelopathy through decompression of neural structures. Fusion in itself is not a requisite to reach this goal. In our center, ACDF with stand-alone cages is the standard procedure for CDDD. Plate-constructs are only used on indication. A common concern regarding ACDF with stand-alone cages is the occurrence of cage subsidence. In our retrospective cohort of 673 patients, only 1 patient required additional surgery due to subsidence (0.15%) \[unpublished data\]. Axial pain alone is not considered an indication for surgical treatment. Good short-term clinical results are achieved for both radiculopathy and myelopathy. Clinical results are independent from the technique used, and independent from occurrence of fusion. However, patient-reported satisfaction gradually decreases in the years following surgery. This is thought to be the consequence of the development of new complaints due to degenerative changes at a segment adjacent to the site of the index surgery, also known as adjacent segment pathology (ASP). A recent consensus proposes a distinct definition of radiologic adjacent segment pathology (RASP) and clinical adjacent segment pathology (CASP). CASP occurs at an estimated cumulative rate of 1.6% to 4.2% per year after ACDF, however, a wide variety in incidence is reported in literature. About 50-75% of the patients that develop CASP require additional adjacent segment surgery. In our retrospective cohort, we observed a rate of 2.1% CASP per year, with an additional adjacent segment surgery rate of 1.5% per year. Moreover, we found that half of these patients undergo additional surgery for CASP within 2.5 years, which suggests a peak incidence in the first years following index surgery. The underlying mechanism of ASP remains a matter of debate. Besides natural degeneration, compensation for the loss of motion in the fused segment is thought to cause overstraining of the adjacent segments. Altered cervical sagittal alignment is also thought to be of importance in the accelerated development of CASP. Higher rates of CASP are observed after ACD, concomitant with an increased segmental kyphosis at the index level. Unlike ACD, ACDF with plate-constructs restore cervical sagittal lordosis. However, a higher rate of ASP is observed in those with plate-constructs in comparison to ACDF with stand-alone cages. The higher rate of ASP after ACDF with plate-constructs might be explained by strain on the adjacent segments by the plate, or more extensive surgical preparation for installing the plate increasing the chance on destruction of the adjacent level. Another contributing factor might be the occurrence of subsidence of the plate-construct into the adjacent segment. Disc height at the adjacent segments is found to be significantly decreased in those with plate-constructs, which supports this theory. It remains unknown to what extent altered cervical motion influences the development of ASP. Anterior cervical discectomy with arthroplasty (ACDA) was developed to reduce the incidence of CASP by preserving motion in the operated segment. Previously conducted research in patients with radiculopathy and/or myelopathy has shown no significant differences in clinical or radiological outcomes amongst ACDA and ACD(F). A meta-analysis found better neurological outcomes in patients with myelopathy after ACDA, in contrast to the pre-existing notion that ACDA leads to less favorable outcomes in myelopathy due to micro-trauma caused by preserved mobility. Moreover, additional adjacent segment surgery rates are significantly lower for ACDA, both for single- and multilevel surgeries. The difference in additional adjacent segment surgery rates between ACDA and ACDF expands exponentially with a longer-follow-up time. ACDA is often discouraged as the implant costs are higher than those for ACDF whilst clinical outcomes are similar. However, preventing new complaints and additional surgeries due to CASP might be a reason for ACDA to be a more cost-effective technique in the long-term. A systematic review of economic evaluations in anterior cervical decompression surgery was conducted by our research group. The majority of studies report ACDA to be the most cost-effective technique despite higher implant costs. Literature was however strongly heterogeneous and of low quality. In conclusion, there is increasing evidence suggesting that ACDA might be the more cost-effective technique because of a reduced risk on CASP and associated additional surgery rates, compared to ACD(F). High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking, especially in Europe. Therefore, the need for a solid clinical cost-effectiveness trial addressing this question is high.

Background and Rationale Posterior cervical fusion surgeries are performed for degenerative cervical conditions, cervical deformity, cervical tumors, and cervical trauma. They are preferred over an anterior approach when the pathology is located posterior to the spinal cord or when multiple levels must be addressed. Degenerative cervical spondylosis contributes to loss of disc height, facet arthropathy and hypertrophy, and retrolisthesis of the vertebral bodies, all of which can lead to foraminal stenosis, or narrowing around the exiting nerve roots. This is often accompanied by loss of cervical lordosis. During a posterior fusion operation, the restoration of cervical lordosis can worsen this foraminal stenosis and lead to iatrogenic radiculopathy with and estimated incidence between 2.4-50%. Cadaveric studies have shown the insertion of interfacet spacers in the cervical spine increase foraminal height, and serve to indirectly decompress the exiting nerve roots. Another common complication of cervical spine surgery is C5 palsy, which has been reported in 4.6% of patient undergoing posterior cervical spine decompressive procedures, including decompression and fusion. Patients suffering from iatrogenic C5 palsy have significantly increased recovery times, and often require additional services such as imaging studies (CT, MRI) and increased need for physical and occupational therapy, thus increasing costs. Given the ability to decompress the neuroforamen with interfacet spacers, they could potentially be an effective technique for reducing the incidence of C5 palsy. The use of cervical interfacet spacers (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN) is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion. Current techniques for posterior cervical fusion rely on graft placement using bone extenders placed in the posterolateral space, which is not under a compressive load. Wolfe's law dictates that certain amounts of loading of bone grafts is required to achieve bony fusion. Therefore, the use of CIS could potentially increase fusion rates after posterior cervical arthrodesis procedures and reduce or eliminate the need for use of bone graft extenders. Reassuringly, radiologic studies have shown that despite the increase in foraminal height, the use of CIS does not lead to loss of cervical lordosis. Study Objective To date, there have been no prospective studies examining the use of cervical interfacet spacers. The investigators propose to undertake a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Primary Outcome Measures The primary outcome measures will include (i) the rate of cervical fusion measured on post-operative radiographs and CT scans performed at 2-years and (ii) cervical sagittal alignment parameters as measured on post-operative radiographs. Secondary Outcome Measures The secondary outcome measures will include post-operative patient reported outcomes including NRS, NDI, and SF-36 RAND. As well, all neurological adverse events will be prospectively collected.

3D technology is increasingly being used, especially in orthopaedic surgery and traumatology as it allows to define specific objects and to understand structures and system dynamics. From patient TC images and using a biomedical engineering software, an exact 3D virtual model of the anatomical region can be created, enabling visualization, planning and simulation of the entire surgery. Besides, this software allows to design custom-made surgical guides (that precisely define cutting zones and screw positioning) as well as personalized implants that perfectly fit the patient's anatomy. After that, Patient-Specific Instrumentation can be manufactured using 3D printers and biocompatible materials and they can be sterilized to be used in the operating room. While personalized surgical guides increase surgical precision and surgeon satisfaction, personalized implants have shown to generate better clinical outcomes, both short and long term. Despite of the benefits that 3D technology can generate in the medical field, most surgeons still opt for conventional 2D planning techniques, free-hand surgeries and generic implants use. This results in a non-standardized and variable procedure that heavily depends on the surgeon´s experience and in many cases, the obtained results deviate from the initial goals. Scientific evidence shows that a lack of precision is strictly related to clinical complications. Poor alignment of the implants can cause damage to internal structures, increases chances of dislocations, fractures and osteolysis as well as reduces the prosthetic component lifespan. That translates into patient suffering from chronic pain, reduced functionality and an increased number of reinterventions. Regardless of the potential and several applications of 3D technology, there´s still a lack of clinical evidence, and the economic impact is still unknown. This methodology is increasingly being used as a routine medical process in many institutions but still raises concerns regarding costs, specially when considering its use in the public health system. Although digital surgery has a wide variety of associated expenses such as hardware and software cost, equipment maintenance and 3D-specialised engineers, the cost of 3D technology has significantly decreased in the past few years and it can potentially generate economic benefits compared to the standard methodology due to the optimization of the surgical process; shorter surgeries, reduced number of unnecessary sterilized materials, reduced number of fluoroscopies during surgery and less medical complications and revisions. Thus, a large-scale study is still needed to demonstrate: 1) clinical benefits that 3D technology can generate compared to conventional surgery and 2) thoroughly analyse its economic impact to determine if it's a cost-effective methodology. For this reason, a multi-centre, randomized and prospective study is proposed to evaluate digital surgery's clinical results and to perform a cost-effectiveness analysis in order to obtain enough scientific evidence to be able to escalate the use of 3D technology in all public health institutions. This clinical trial is a pragmatic study that will evaluate the efficacy and effectiveness of 3D technology in 3 different surgical procedures; distal radius osteotomy, acetabular arthroplasty and spinal arthrodesis.