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Spinal Fractures clinical trials

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NCT ID: NCT06153576 Completed - Lymphoma Clinical Trials

The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures

Start date: January 1, 2016
Phase:
Study type: Observational

Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. The question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? Methods: The investigators carried out a single-centre retrospective study at Nice University Hospital. From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients. The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a coagulation test. The imaging work-up systematically included MRI, unless contraindicated, in which case CT alone was performed. Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic guidance. The systematic biopsy sample was then sent to the anatomopathology department for analysis. Findings : The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion. All the incidental findings were haemopathies, including 4 myelomas and one lymphoma. Conclusion : These results highlight the good performance of MRI in distinguishing osteoporotic vertebral fractures from solid tumour metastases. However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion. The investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.

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: NCT05803681 Completed - Vertebral Fracture Clinical Trials

CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

in recent years the search for therapeutic protocols that could enhance the VFFs healing, thus reducing bed rest-related complications and improving the quality of life of osteoporotic patients. In this context, biophysical stimulation with Capacitively Coupling Electric Fields (CCEF) together, antiresorptive therapy, vitamin D supplementation, and analgesic drugs could play a central role. CCEF is a non-invasive type of biophysical stimulation used to enhance fracture repair and spinal fusion. Positive effects of CCEF have been reported in osteoporotic vertebral fractures to resolve chronic pain and in postoperative pain, disability, and quality of life after spinal fusion In a preliminary observational study, Piazzolla et al. showed a significantly faster VBME resolution and back pain improvement in patients suffering from VFFs.

NCT ID: NCT05526794 Completed - Vertebral Fracture Clinical Trials

Anesthesia Methods on Percutaneous Kyphoplasty

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP). Method: Patients were split into three groups according to anesthesia methods: (1) General Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)]. Patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with Visual Pain Scales (VAS).

NCT ID: NCT05244031 Completed - Postoperative Pain Clinical Trials

Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

NCT ID: NCT05227976 Completed - Osteoporosis Clinical Trials

Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis

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

In the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture). The study includes a 10-week intervention period with once weekly theory education with or without additional physical training or mindfulness/medical yoga (randomized groups). Furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up post-intervention observation are included in the study design.

NCT ID: NCT05071625 Completed - Vertebral Fracture Clinical Trials

CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation

Start date: March 31, 2019
Phase:
Study type: Observational

Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option. The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation. All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.

NCT ID: NCT04980131 Completed - Vertebral Fracture Clinical Trials

Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator

Start date: June 6, 2018
Phase: N/A
Study type: Interventional

This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.

NCT ID: NCT04956588 Completed - Spine Disease Clinical Trials

Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.

NCT ID: NCT04774029 Completed - Vertebral Fracture Clinical Trials

Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management

Start date: January 10, 2020
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.