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Spinal Diseases clinical trials

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NCT ID: NCT03461458 Terminated - Clinical trials for Degenerative Disc Disease

Autologous, Culture-Expanded Mesenchymal Stromal Cells for Degenerative Disc Disease

Start date: October 17, 2018
Phase: Phase 1
Study type: Interventional

To determine the safety and feasibility of autologous, culture-expanded adipose-derived (AD) mesenchymal stromal cells (MSCs) in subjects with painful degenerative disc disease (DDD).

NCT ID: NCT03417193 Completed - Postoperative Pain Clinical Trials

Opioid Free Anesthesia and Major Spine Surgery

Start date: January 29, 2018
Phase: N/A
Study type: Interventional

This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

NCT ID: NCT03367039 Not yet recruiting - Clinical trials for Cervical Disc Disease

A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.

NCT ID: NCT03360409 Not yet recruiting - Clinical trials for Cervical Disc Degeneration

Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA), a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

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: NCT03256149 Withdrawn - Dysphagia Clinical Trials

High Dose Steroids for Dysphagia

SHDD
Start date: March 24, 2015
Phase: N/A
Study type: Interventional

Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.

NCT ID: NCT03249363 Completed - Spinal Fusion Clinical Trials

Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery

Start date: January 1, 2010
Phase: N/A
Study type: Interventional

The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach. To confirm and better assess the efficacy of intraoperative irrigation on the infection rate in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular tissue before and after irrigation of the wounds

NCT ID: NCT03246399 Terminated - Clinical trials for Degenerative Disc Disease

A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease

Start date: July 26, 2017
Phase: Phase 1
Study type: Interventional

SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135, and 180.

NCT ID: NCT03214536 Completed - Spine Disease Clinical Trials

Erector Spine Block for Back Surgery

Start date: June 25, 2017
Phase: N/A
Study type: Interventional

In spine surgery postoperative pain can often be severe and difficult to treat.With the use of ultrasound, the performance of plane blocks and other techniques like root blocks, facet infiltration have become possible without the use of either unreliable " pop-techniques" or the use of x-ray.The erector spinae block was recently described as a safe and simple and safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal rami of the spinal nerves and with promising results. In this observational pilot study we want to test the influence of these to blocks on the postoperative pain and opioid consumption after spine fusion.

NCT ID: NCT03187171 Withdrawn - Surgery Clinical Trials

ACDF Comparison Trial

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device. This clinical study presents little to no additional risk to study subjects beyond those associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an ACDF procedure will be enrolled in the study. The study consists of a completing a series of questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate of successful spinal fusion for each group. For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to the device used and/or procedures performed.