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Spinal Stenosis clinical trials

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NCT ID: NCT06290908 Completed - Spinal Stenosis Clinical Trials

RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

Start date: September 4, 2018
Phase:
Study type: Observational

Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.

NCT ID: NCT06153511 Completed - Clinical trials for Lumbar Spinal Stenosis

Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation

Start date: November 16, 2022
Phase: N/A
Study type: Interventional

This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation. The study, conducted in two different hospital centers, involves patients with vertebral fractures, spinal stenosis, kyphosis, and other related conditions. The primary objective is to determine screw accuracy by assessing the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. Trained radiologists will evaluate the screw invasion into the pedicle. The study is scheduled to span 12 months and each intervention includes a 1-month follow-up. Throughout this time frame, patients will undergo regular assessments, and outcomes will be closely monitored.

NCT ID: NCT06079580 Completed - Clinical trials for Lumbar Spinal Stenosis

Patients With Lumbar Spinal Stenosis With Balance Disorder

Start date: September 1, 2023
Phase:
Study type: Observational

It is seen that patients with Lumbar Spinal Stenosis often experience balance problems. Although the relationship between muscle thickness and balance has been explained, there are insufficient studies investigating the relationship between balance problems and muscle thickness in patients with LSS. In addition, no study has been found comparing the difference in muscle thickness and cross-sectional area in LSS patients with poor and normal balance. In addition, in LSS, pain, disability and fear of falling in balance disorders are nor clear. The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

NCT ID: NCT06060821 Completed - Spinal Stenosis Clinical Trials

Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this study was to investigate the validity and reliability of the 2 Minute Step Test (2MST) in patients with symptomatic degenerative lumbar spinal stenosis and to explore its correlation with objective assessment methods, namely the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT).

NCT ID: NCT05959343 Completed - Clinical trials for Lumbar Spinal Stenosis

Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

Start date: July 12, 2023
Phase: N/A
Study type: Interventional

This study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'Early Recovery After Surgery Clinical Pathway (ERAS CP)' on patient-reported pain levels at the time of discharge following Oblique Lumbar Interbody Fusion (OLIF) surgery

NCT ID: NCT05871073 Completed - Clinical trials for Lumbar Spinal Stenosis

Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

Introduction: Improving postoperative pain management after spinal surgery is a significant challenge for surgeons and anesthesiologists. Pain following spinal surgery, can lead to significant morbidity, limit early mobility, and increase the risk of chronic pain. This trial examines the analgesic effects of dexamethasone as an adjuvant to ropivacaine in wound infiltration after lumbar surgery. Methods: In this study, we randomly assigned sixty patients undergoing lumbar laminectomy and/or osteosynthesis into two groups of 30 patients each. The control group (R-group) received only Ropivacaine (150 mg of Ropivacaine 7.5% (20 ml) added to 2 ml of normal saline in the wound infiltration), while the intervention group (RD-group) received Ropivacaine with the addition of dexamethasone (150 mg of Ropivacaine 7.5% (20 ml) added to 8 mg of dexamethasone in the wound infiltration). Both groups were administered patient-controlled analgesia (PCA) with morphine for self-medication. Postoperatively, a blinded evaluator assessed pain at H0, recorded the assessment of surgical scar pain using the Visual Analog Scale (VAS) at 4, 6, 12, 24, and 48 hours, as well as the time to the first opioid request, cumulative morphine consumption, opioid-related side effects, and length of stay. All patients were scheduled for a 3-month follow-up call to monitor chronic pain progression.

NCT ID: NCT05630404 Completed - Clinical trials for Lumbar Spinal Stenosis

Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

Start date: November 28, 2022
Phase: N/A
Study type: Interventional

Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery.

NCT ID: NCT05619848 Completed - Clinical trials for Spinal Stenosis Lumbar

Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery

RUILS
Start date: October 25, 2022
Phase: Early Phase 1
Study type: Interventional

To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.

NCT ID: NCT05548608 Completed - Clinical trials for Spinal Stenosis Lumbar

Lumbar Proprioception in Patients With Lumbar Spinal Stenosis

Start date: September 10, 2020
Phase:
Study type: Observational [Patient Registry]

The primary aim of this study was to compare spinal proprioception in patients with Lumbal Spinal Stenosis (LSS) (with or without surgery) and healthy controls. A secondary aim was to investigate the effect of pain at target positions where repositioning error (RE) was assessed and TLF flexibility on spinal proprioception deficiency.This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.

NCT ID: NCT05525052 Completed - Spinal Stenosis Clinical Trials

Percutaneous Trans-facet Screw Fixation Under CT-scan Guidance for Remaining Symptoms at a Distance of Previous Spinal Surgery

Start date: January 1, 2021
Phase:
Study type: Observational

Background : Segmental spinal instability after a laminectomy, and adjacent segment disease (ASD) at after an arthrodesis, are well-known concerns in spinal surgery, which may require re-interventions, usually by surgical arthrodesis, posing the problem of a new heavy intervention under general anesthesia, in often fragile patients. Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability. Purpose : The aim of our study is to evaluate the efficacy, in terms of pain reduction (VAS) and improvement of daily activities (ODI), of TFF under CT scan guidance in the context of low back pain and/or radiculalgia related to focal instability secondary to laminectomy or ASD. Methods : TFF were performed in 24 patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis and remaining symptomatic, at Nice University Hospital between 2017 and 2021 Pre- and postoperative pain and disability levels were measured using the visual analogue scale (VAS) and the Oswestry Disability Index (ODI), collected prospectively at systematic 6-month and 1-year follow-up visits. Long term evolution were assessed by phone consultation.