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Spondylolisthesis clinical trials

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NCT ID: NCT03459404 Completed - Postoperative Pain Clinical Trials

Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation

Start date: September 19, 2018
Phase:
Study type: Observational

The Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is a patient-controlled analgesia (PCA) system approved in September 2015 by the European Commission for the management of acute moderate-to-severe pain in adult patients in a hospital setting. This preprogrammed drug/device combination product delivers a fixed dose of 15 mcg of sufentanil tablets as needed, in a non-invasive sublingual dosage form. Multimodal analgesia is defined as the administration, by one or more routes, of various analgesic medications with different mechanisms of action, thereby providing superior analgesia with fewer side effects. To improve pain control and patient satisfaction, patient-controlled analgesia (PCA) techniques have been developed, i.e. any delivery system which allows patients to self administer predetermined doses of analgesic drug to relieve pain. Over the past decades, intravenous (IV) PCA with morphine has been the gold standard for acute pain control. In our clinical practice, though, not only IV-PCA pumps were frequently prone to technical problems, but also patients and caregivers were not often able to understand or activate them, thus raising important safety issues and profoundly affecting the management of pain control. As a consequence, IV-PCA eventually fell into disuse, although no alternative has emerged until recently. The SSTS should go beyond the above-quoted limitations: it is a non invasive, patient-controlled and easy to use device, with an effective and safe opioid profile. It is, in our thinking, a promising technology. The aim of this retrospective analysis is to examine the role of the SSTS for management of pain after vertebral surgery, as part of a multimodal approach.

NCT ID: NCT03434223 Terminated - Spinal Stenosis Clinical Trials

Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)

Start date: December 29, 2016
Phase:
Study type: Observational [Patient Registry]

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

NCT ID: NCT03425682 Completed - Clinical trials for Degenerative Disc Disease

ViBone in Cervical and Lumbar Spine Fusion

Start date: May 14, 2018
Phase:
Study type: Observational

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

NCT ID: NCT03398915 Recruiting - Clinical trials for Degenerative Disc Disease

The European Robotic Spinal Instrumentation (EUROSPIN) Study

EUROSPIN
Start date: February 20, 2018
Phase:
Study type: Observational [Patient Registry]

In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.

NCT ID: NCT03381677 Suspended - Clinical trials for Lumbar Spinal Stenosis

Pedicle Osteotomy for Stenosis Trial

POST
Start date: October 26, 2017
Phase: N/A
Study type: Interventional

This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.

NCT ID: NCT03344484 Not yet recruiting - Clinical trials for Spondylolisthesis, Lumbar Region

Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03327298 Completed - Clinical trials for Lumbar Spondylolisthesis

Free Hand Lumbar Pedicular Screw Fixation

Start date: May 10, 2014
Phase: N/A
Study type: Interventional

Background: Different methods for lumbar pedicular screw insertion have been advocated, however each technique has its cons and pros. Due to limited resources for O-Arm and navigation in our locality, the investigator was enforced to use the surgical skills to minimize the need for such advanced modalities. Aim of the study: Is to clarify the benefits of the use of free hand technique using direct visualization of the pedicles and disc space as the only guide for pedicular screw insertion using postoperative CT for evaluation of the accuracy of pedicle screw insertion. Patients and methods: One hundred and forty four screws were inserted in 32 patients using direct pedicle visualization and disc space orientation as a single intraoperative reference guide. The study was conducted in Zagazig University Hospitals from May, 2014 to June, 2015. CT was done for all patients as a direct postoperative evaluation tool.

NCT ID: NCT03321357 Completed - Clinical trials for Degenerative Disc Disease

Retest-reliability and At-home-assessment Feasibility of the 5R-STS

5RSTS-2
Start date: December 8, 2017
Phase:
Study type: Observational

The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine. The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.

NCT ID: NCT03303300 Completed - Clinical trials for Degenerative Disc Disease

The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy

5R-STS
Start date: October 1, 2017
Phase: N/A
Study type: Observational

The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but has never been correlated with or validated in regard to degenerative spinal diseases. The investigators aim to assess the possibility of using the standardized 5R-STS as an objective measure of functional impairment and pain severity in patients with degenerative lumbar spinal diseases.

NCT ID: NCT03271060 Not yet recruiting - Clinical trials for Lumbar Spondylolisthesis

Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach. While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).