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Spinal Fractures clinical trials

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NCT ID: NCT04495439 Terminated - Clinical trials for Osteoporotic Fracture of Vertebra

Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture. The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.

NCT ID: NCT03359941 Terminated - Fractures, Bone Clinical Trials

Acupuncture Treatment for Vertebral Compression Fracture

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life). Objective: This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.

NCT ID: NCT02931266 Terminated - Spinal Fractures Clinical Trials

PASS MIS® Post-market Clinical Follow-up

Start date: September 2016
Phase:
Study type: Observational

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

NCT ID: NCT02788760 Terminated - Clinical trials for Collar Treatment of Stable Subaxial Spine Fractures

"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"

Start date: June 2016
Phase: N/A
Study type: Interventional

Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

NCT ID: NCT02489825 Terminated - Osteoporosis Clinical Trials

Study About the Effect of Preventive Adjacent Level Cement Augmentation After Osteoporotic Vertebral Compression Fractures

Start date: January 2015
Phase: Phase 4
Study type: Interventional

Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized controlled trials (RCTs) with substantial methodological problems have led to an intense discussion another RCT with larger case numbers, more representative inclusion criteria and a more consistent and sound methodology has revealed results that mirror the investigators' own clinical experience. In their daily practice, the investigators have further advanced their treatment concept and routinely apply prophylactic augmentations with VP using an algorithm. Biomechanical studies support their approach, but clinical studies are rare so far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a small pilot study. Given the above mentioned methodological and clinical disputes and the call for high-evidence studies about VP, the investigators aim at generating a reliable sample size calculation and preliminary results for a future multicenter RCT about prophylactic adjacent level augmentation with VP in single level osteoporotic compression fractures.

NCT ID: NCT02376933 Terminated - Multiple Myeloma Clinical Trials

Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

Start date: August 20, 2013
Phase: N/A
Study type: Interventional

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

NCT ID: NCT01001715 Terminated - Back Pain Clinical Trials

Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

Start date: November 2009
Phase: Phase 2
Study type: Interventional

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture. Secondary objectives were: - to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain; - to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

NCT ID: NCT00961714 Terminated - Clinical trials for Vertebral Compression Fractures

OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

OsseoFix
Start date: August 2009
Phase: N/A
Study type: Interventional

The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement. The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US. This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.

NCT ID: NCT00749229 Terminated - Clinical trials for Located Between T11 and L5

Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation

TRAUMAA3B1C1
Start date: December 2007
Phase: Phase 4
Study type: Interventional

Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance. Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.

NCT ID: NCT00748631 Terminated - Multiple Myeloma Clinical Trials

Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.

KYPHOK
Start date: October 2007
Phase: N/A
Study type: Interventional

Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications. This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure. Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient. The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.