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Fractures, Compression clinical trials

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NCT ID: NCT05337696 Recruiting - Clinical trials for Vertebral Compression Fractures

Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant

RECONSTRUCT
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (<8week) vertebral compression fractures who have failed conservative care strategies.

NCT ID: NCT04835428 Recruiting - Clinical trials for Vertebral Compression Fracture

STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures

Start date: May 31, 2022
Phase: N/A
Study type: Interventional

This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.

NCT ID: NCT04821739 Recruiting - Vertebral Fracture Clinical Trials

RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.

NCT ID: NCT04581707 Recruiting - Clinical trials for Vertebral Compression Fracture

Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement

Start date: March 1, 2020
Phase:
Study type: Observational

The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.

NCT ID: NCT04064710 Recruiting - Clinical trials for Vertebral Body Compression Fracture(s)

Biological Allograft Chain Tissue Implant

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.

NCT ID: NCT03621527 Recruiting - Clinical trials for Vertebral Compression Fractures in Osteoporotic Patients

Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty

VTB EPI-AL
Start date: May 3, 2018
Phase: N/A
Study type: Interventional

Vertebral compression fractures in osteoporotic patients is a major healthcare problem. Percutaneous vertebroplasty is commonly used to restore stability of the vertebra and to alleviate pain. However, the anesthetic techniques commonly used during these procedures such general anesthesia or a combination of local anesthesia and sedation are not satisfying as they are associated either with side effects or insufficient pain reduction. This study compares the standard procedure of local anesthesia to a new technique of fluoroscopy-guided epidural anesthesia carried out by the radiologist. The investigator's hypothesis is that fluoroscopy-guided epidural anesthesia - provides better pain relief during the injection of high viscosity cement - and thus, reduces the need of additional intravenous analgesia by remifentanil (morphine analogue) - minimizes remifentanil potential adverse effects such as respiratory depression, hypoxemia, pruritus and nausea - improves working conditions and satisfaction of the radiologist - improves the global satisfaction of the patient It is a monocentric, prospective, comparative and randomized study.

NCT ID: NCT03451305 Recruiting - Clinical trials for Osteoporosis Fracture

Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

Start date: January 23, 2018
Phase: N/A
Study type: Interventional

Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.

NCT ID: NCT02085811 Recruiting - Thoracolumbar Spine Clinical Trials

Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

KIPHO
Start date: June 2013
Phase: N/A
Study type: Observational

The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures. Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU. An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination. The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.

NCT ID: NCT01609712 Recruiting - Lung Function Clinical Trials

Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation

Start date: May 2012
Phase: N/A
Study type: Observational

Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume. Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture. In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.

NCT ID: NCT01281826 Recruiting - Clinical trials for Spinal Compression Fracture

Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to 1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image compared with MR imaging as standard reference. 2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual noncalcium images, such as the morphologic signs, visual qualitative detection, and quantitative values.