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Fractures, Compression 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: NCT05058443 Completed - Clinical trials for Osteoporotic Vertebral Compression Fracture

Denosumab and Osteoporotic Vertebral Compression Fracture

Start date: January 6, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

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.

NCT ID: NCT04135755 Completed - Posture Clinical Trials

The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects

Start date: March 16, 2015
Phase:
Study type: Observational

This study aimed to assess the sensory and kinematic components of the limits of stability (LOS) test in patients with vertebral compression fracture (VCF) .

NCT ID: NCT03580434 Completed - Clinical trials for Vertebral Compression Fracture

The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.

NCT ID: NCT03523000 Completed - Clinical trials for Chronic Low Back Pain

Determining the Prognostic Value of Continuous Intrathecal Infusion

Start date: October 18, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes for treatment with intrathecal implantable devices. The investigators will compare the primary outcomes [changes in pain intensity score (NRS), patient global impression of change (PGIC)] before and after intrathecal infusion of an admixture of bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml versus normal saline. The study will include 36 patients with intractable chronic low back pain in the setting of lumbar post-laminectomy syndrome or vertebral compression fracture who failed conservative management and are considered candidates for IDDS. Prior to the implant, the patients will undergo an intrathecal prognostic infusion test with an externalized catheter. Baseline NRS pain scores will be assessed and documented on all patients upon admission to the preoperative area. An intrathecal catheter will be placed in the outpatient procedure suite at the appropriate level for target dermatomes. The needle entry point will occur in the upper lumbar spine and catheter tip will be placed in the lower thoracic spine, under local anesthesia with the patient awake and with minimal or no sedation. The intrathecal infusion will be started using an external pump once patient is in the PACU. The research component is to perform the intrathecal test with normal saline (inactive placebo solution) in addition to a test with fentanyl and bupivacaine (active solution). Patients will be randomly assigned to either Group I (continuous infusion of bupivacaine and fentanyl followed by saline) or Group II (continuous infusion of saline followed by bupivacaine and fentanyl). In PACU, patients will be started on an infusion rate of 0.5 ml/hr and titrated to pain relief greater than 50% of baseline or up to 0.8-1.0 ml/hr within 6-8 hrs after start of the infusion. A clinician blinded to the treatment arm will assess NRS and PGIC on the patients after approximately 12 hours. Assessment will include changes in pain intensity score at rest and upon ambulating or performing maneuvers that normally elicit patient's low back pain. A 4-6-hour washout period will be allotted with infusion of preservative-free normal saline at a rate of 0.2 ml/hr, after which the physician will document a return of the NRS to baseline before switching therapies.

NCT ID: NCT02902250 Completed - Clinical trials for Osteoporotic Vertebral Compression Fracture

The Comparative Study About the Effect of Vertebral Body Decompression Procedure

Start date: June 8, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design

NCT ID: NCT02657265 Completed - Trauma Clinical Trials

SpineJack® Versus Conservative Treatment Study (SPICO Study)

Start date: January 13, 2016
Phase: N/A
Study type: Interventional

This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows: 1. SpineJack® system 2. Conservative Orthopedic Management consisting of brace and pain medication.

NCT ID: NCT02608801 Completed - Hip Fractures Clinical Trials

Prediction and Secondary Prevention of Fractures

NOFRACTsub
Start date: April 2015
Phase:
Study type: Observational

The purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.

NCT ID: NCT02476981 Completed - Clinical trials for Fractures, Compression

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty

Start date: August 2012
Phase: N/A
Study type: Interventional

This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored anaesthesia care (MAC) during minimally invasive corrections of vertebral compression fracture (vertebroplasty (VP) and kyphoplasty (KP)). In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple hemodynamic variables of patients were recorded and the frequency of oxygen desaturation, respiratory depression, intraoperative need for other opioids, recovery time, operator satisfaction score, and patients' overall pain experiences were also compared. The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP and KP in elderly patients.