Active clinical trials for "Spondylolisthesis"

Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.

The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.

Catastrophizing has emerged as the strongest independent predictor for persistent postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy (CBT), have been shown to reduce the impact of persistent pain, postsurgical patients have not historically been offered these interventions. The aim of our study is to examine whether an intervention targeting pain catastrophizing can reduce the risk of persistent pain and disability after spinal fusion. Our primary hypothesis is that a perioperative cognitive behavioral intervention with the goal to decrease anxiety and pain catastrophizing will decrease the risk of persistent pain and disability after spinal fusion surgery in high catastrophizing patients. To study this hypothesis the investigators will perform a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing 2 cohorts. Patients aged > 18 years/old, with a primary diagnosis of spinal stenosis, degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine surgeons and selected for lumbar spinal fusion surgery with decompression will be screened for high levels of pain catastrophizing using the Pain Catastrophizing Scale (PCS). Patients with a score of ≥ 24 on the PCS who will consent to the study will be randomized to CBT (2 sessions preoperatively and 4 sessions postoperatively) plus usual care (experimental group) or usual care (control group). To limit expectation bias, an educational intervention will be added in the control group. Primary outcome is the Core Outcome Measure Index (COMI) at 12 months. Secondary outcomes are scores on 11-point Numeric Rating Scale (NRS) for back and leg pain, Oswestry Disability Index (ODI), Patient-reported outcomes measurement - depression (PROMIS-D), Patient Global Impression of Change (PGIC), Pain Catastrophizing (PCS), reliance on analgesics and employment status. NRS will be measured on the 4th postoperative day, at 8 weeks, 6 months and 1 year, while all other outcomes will be measured at 8 weeks, 6 months and 1 year.

Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction. Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively. Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.

Aim of research is to investigates clinical, surgical and radiological outcome of vertebral pars intetarticularis repair by used smile face shape rod technique and bone grafting and comparing that with posteriolateral fusion with used traditional transpedical screw and rod fixation in management of isthmic spondylistheisis

Alpha-agonist in anesthesia display immunomodulatory effect in addition to antiadrenergic control. This effect of the immune system can be a key to a better perioperative safety and quality. The association of dexmedetomidine at general anesthesia adds up organic protection and inflammatory control to a surgery trauma owing to antinociception and immunomodulatory effect. The aim this study is evaluate if the association of dexmedetomidine at general anesthesia standing effective immunomodulatory control to trauma and improve changes at outcomes in patients undergoing to spinal fusion.

Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

For the increasing numbers of patients undergoing fusion procedures for the degenerative lumbar spine, infection and re-operation can negatively impact outcomes. Numerous observational and retrospective reviews have shown advantages to para-median versus midline approaches; however, recent systematic reviews have shown a need for a well-powered, prospective randomized control trials comparing both exposures. As a step towards a long-term goal of an RCT to address this issue, the purpose of this pilot study is to gather initial data to examine whether operative approach impacts the short-term infection rate, re-operation rate, length of stay, and overall costs to the system. Patients deemed appropriate surgical candidates with single or two-level degenerative spondylolisthesis will be approached for participation, and randomized into either the midline or paramedian group. Initial follow-ups will be at 2 and 6 weeks, and 3 months. Infection rates, inpatient and outpatient adverse events, re-operation rates, radiation exposure and costs will be determined. Cost effectiveness analysis will be estimated comparing each procedure using a bottom-up estimation. Post-operative wound infection can have a significant effect on patient short and long term outcomes. If a significant difference in infection rate is demonstrated, as well as lower re-operation rates, shorter stays, and decreased overall costs, adoption of paramedian approaches to single or two-level fusions of the lumbar spine might be suggested, providing fuel for a full-scale RCT.

Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies. The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results. Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound guidance for perioperative pain management in various surgeries.However, the plane for a posterior QL block can be easily reached during open midline spinal surgery. The investigators hypothesize that the posterior QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative to test the benefits of this procedure. This is a double blinded randomized control study to assess the results of intra-operative QL block performed for lumbar decompression and fusion.