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Spinal Fractures clinical trials

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NCT ID: NCT06374472 Completed - Spine Fracture Clinical Trials

Surgical Treatment of Fractures of the Dorso-lombar Spine

Start date: January 1, 2018
Phase:
Study type: Observational

Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis

NCT ID: NCT06367582 Recruiting - Vertebral Fracture Clinical Trials

SPINE BONE CEMENTS OUTCOMES

Start date: September 4, 2019
Phase:
Study type: Observational

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

NCT ID: NCT06200298 Not yet recruiting - Pain, Postoperative Clinical Trials

Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures

SPINERECTOR
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

Spinal fracture surgery is a common surgery. Post-operative pain has been reduced by the advent of so-called minimally invasive techniques. The immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma. The erector spinae plane block (ESPB) is a loco-regional anesthesia technique first described in 2016. A retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use. In order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study. The objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. The expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.

NCT ID: NCT06172179 Recruiting - Prediction Model Clinical Trials

Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty

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

"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."

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: NCT06141187 Recruiting - Vertebral Fracture Clinical Trials

Percutaneous Vertebroplasty vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

VOPE2
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.

NCT ID: NCT06092775 Not yet recruiting - Vertebral Fracture Clinical Trials

Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

Start date: December 2023
Phase:
Study type: Observational

Study of prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis

NCT ID: NCT06059820 Recruiting - Spine Fusion Clinical Trials

Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit

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

The goal of this observational study is to compare the long-term clinical outcomes of two treatment methods (conservative therapy and surgical treatment) in patients with fractures of the thoracic and lumbar spine without neurological deficit

NCT ID: NCT05995327 Recruiting - Spine Deformity Clinical Trials

Reasons and Risk Factors for Unplanned Spinal Re-operation

Start date: January 1, 2012
Phase:
Study type: Observational

Unplanned re-operation is one of the common negative indicators reflecting the quality and safety of surgery in the medical industry and has become one of the ten goals for the improvement of national medical quality and safety in China since 2022, while about 40% of unplanned re-operations in Peking University Third Hospital in recent years occur in spine patients of the orthopedics department. This project intends to establish a high-quality and sustainable ambispective disease cohort for spine surgery in Peking University Third Hospital based on the unplanned re-operations that occurred in the Orthopedics Department of Peking University Third Hospital from January 2012 to December 2025. The investigators further summarize and analyze clinical causes and risk factors of re-operations, aiming to explore scientific coping strategies and provide reference for continuous improvement of medical service quality.