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Fractures, Compression clinical trials

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NCT ID: NCT06379243 Recruiting - Clinical trials for Osteoporosis Fracture

Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

In this project, IDEAL-IQ technology and PDFF and R2* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).

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: NCT06270173 Recruiting - Clinical trials for Osteoporotic Vertebral Compression Fractures

Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures

Start date: February 16, 2024
Phase: N/A
Study type: Interventional

The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.

NCT ID: NCT06261242 Recruiting - Clinical trials for Osteoporotic Vertebral Compression Fractures

Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment

Start date: June 16, 2023
Phase: N/A
Study type: Interventional

This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures.

NCT ID: NCT06174077 Recruiting - Clinical trials for Vertebra Compression Fracture

Monitoring of Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Procedures

CIMVER
Start date: October 6, 2020
Phase:
Study type: Observational

The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation. The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection

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: 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: NCT06093087 Not yet recruiting - Clinical trials for Osteoporotic Vertebral Compression Fracture

Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease

Start date: January 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation

NCT ID: NCT05912504 Recruiting - Clinical trials for Vertebral Compression Fracture

Long Term Follow-up of Vertebral Compression Fracture In-patients Treated: A Retrospective Chart Review and Survey

Start date: January 20, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Acute Vertebral Compression Fracture in-patients by observing inpatients treated with integrative Korean medicine. This study is a retrospective observational study. The subjects for study are patients diagnosed with Acute Vertebral Compression Fracture and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2022.06.30. Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Oswestry Disability Index(ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.