Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071625
Other study ID # 21Imagerie02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 31, 2019
Est. completion date September 15, 2021

Study information

Verified date September 2021
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option. The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation. All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 15, 2021
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - PVP performed between July 2015-July 2020 under combined CT and fluoroscopy guidance; - Previous PF for traumatic non-neurological thoracolumbar vertebral fracture; - Imaging evidence of vertebral non-union; - Pain and functional impairment persisting for more at least one month after PF; - Informed patient consent for PVP procedure under CT and fluoroscopy guidance; - Previous multidisciplinary case discussion between spine surgeons and interventional radiologists. Exclusion Criteria: - Age inferior to 18 years old - Absence of complications due to orthopaedic hardware;

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
percutaneous vertebroplasty
percutaneous vertebroplasty under combined CT/fluoroscopy guidance for non-union after posterior fixation performed for a traumatic non-neurologic thoraco-lumbar vertebral fracture.

Locations

Country Name City State
France CHU de NICE Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty Numeric Pain Rate Scale (from 0 to 10 points, where 0 no pain, 10 maximum pain) 18 months
Secondary Technical success of the percutaneous vertebroplasty criteria of cement filling rate of vertebral body established by the authors 18 months
Secondary Safety of the procedure Complication rate during and after the procedure using CIRSE adverse event reports 18 months
See also
  Status Clinical Trial Phase
Recruiting NCT06367582 - SPINE BONE CEMENTS OUTCOMES
Completed NCT00463905 - Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures N/A
Terminated NCT00748631 - Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty. N/A
Completed NCT03885466 - Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis N/A
Active, not recruiting NCT05283148 - Sickle Cell Disease (SCD) Bone Pain Study N/A
Completed NCT03839732 - Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry
Recruiting NCT04609150 - Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)
Completed NCT03263585 - Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group N/A
Completed NCT02536898 - Norwegian Capture the Fracture Initiative N/A
Completed NCT01963039 - A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V) N/A
Completed NCT01120197 - Study of Effect of Exercise With Osteoporosis and Vertebral Fracture N/A
Recruiting NCT04821739 - RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures N/A
Recruiting NCT04533217 - Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma. N/A
Completed NCT05227976 - Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis N/A
Completed NCT04980131 - Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator N/A
Completed NCT01839682 - Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis N/A
Not yet recruiting NCT06449742 - A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Completed NCT03617094 - Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures N/A
Active, not recruiting NCT01374412 - Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging
Completed NCT01817933 - Integrated Rehabilitation Program for Fractures N/A