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Fusion of Spine clinical trials

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NCT ID: NCT06367855 Not yet recruiting - Surgery Clinical Trials

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial

MIS-TLIF
Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.

NCT ID: NCT06066879 Recruiting - Fusion of Spine Clinical Trials

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

KIPSs
Start date: September 18, 2023
Phase: Phase 4
Study type: Interventional

To determine if a pre-operative ketamine infusion would provide a similar decrease in post-operative analgesic and opioid consumption as intra-operative ketamine, but expand the monitoring period through the post-operative phase up to 90 days. Hypothesis is that pre-operative ketamine infusion will lead to a decrease in narcotic consumption from baseline following an elective cervical or lumbar fusion, leading to increased functionality and quality of life for these patients.

NCT ID: NCT06024785 Not yet recruiting - Spinal Stenosis Clinical Trials

Vertebropexy - Randomized-controlled Trial

VPRCT
Start date: September 2024
Phase: N/A
Study type: Interventional

To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)

NCT ID: NCT05345249 Completed - Clinical trials for Lumbar Spinal Stenosis

Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery

RCT-ESPB
Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity. Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo. Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial. Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels. Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery. Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.

NCT ID: NCT04891432 Recruiting - Fusion of Spine Clinical Trials

Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach

Start date: April 8, 2021
Phase:
Study type: Observational [Patient Registry]

There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.

NCT ID: NCT04623593 Recruiting - Clinical trials for Cervical Spondylosis

Cervical Arthroplasty Cost Effectiveness Study (CACES)

CACES
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

To date, no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). It remains unknown to what extent kinematics, surgery-induced fusion and natural history of disease play a role in its development. Anterior cervical discectomy with arthroplasty (ACDA) is thought to reduce the incidence of CASP by preserving motion in the operated segment. ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF. However, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term. In this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months till 4 years postoperatively. High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking, to date no prospective trials from a societal perspective exist. Considering the ageing of the population and the rising healthcare costs, the need for a solid clinical cost-effectiveness trial addressing this question is high.

NCT ID: NCT04611490 Recruiting - Safety Issues Clinical Trials

Preoperative and Peroperative Comparison Between 3D Spine Reconstructions

Spine-PDCA-OR
Start date: July 30, 2020
Phase:
Study type: Observational

The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system. The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.

NCT ID: NCT04415814 Recruiting - Fusion of Spine Clinical Trials

Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.

NCT ID: NCT04176562 Recruiting - Clinical trials for Musculoskeletal Diseases

Prospective SPINE Registry

SPINE
Start date: January 28, 2020
Phase:
Study type: Observational [Patient Registry]

This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.

NCT ID: NCT03593330 Recruiting - Surgery Clinical Trials

Neurosurgical Transitional Care Programme

TCP
Start date: April 15, 2018
Phase: N/A
Study type: Interventional

Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. Recently, a readmission reduction program in the United States was associated with significantly shorter length of stay, earlier discharge, and reduced 30-day readmission after elective neurosurgery. These results underscore the importance of patient education and surveillance after hospital discharge, and it would be beneficial to test whether the same approach yields beneficial results in a different health system, the NHS. In this study, the investigators will replicate the Transitional Care Program (TCP) published by Robertson et al.(Journal of Neurosurgery 2017) with the goal of decreasing length of stay, improving discharge efficiency, and reducing readmissions in neurosurgical patients by optimizing patient education and post-discharge surveillance.