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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04453163
Other study ID # 2020-A00600-39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 17, 2020
Est. completion date December 19, 2022

Study information

Verified date January 2023
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research aims to demonstrate the benefits of the RAAC program for patients undergoing cementoplasty, in particular on their level of anxiety and pain control throughout the perioperative phase.


Description:

The aim of the study is to compare the preoperative anxiety of patients hospitalized for a percutaneous vertebroplasty, depending on whether or not they are managed in an RAAC program.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 19, 2022
Est. primary completion date December 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 80 years or = 18 years with oncological history; - Patient with vertebral compression fracture with indication for percutaneous vertebroplasty; - Patient seen in preoperative anesthesia / radiology consultation more than 4 days before the date of the vertebroplasty; - Having expressed their consent to participate in the study. Exclusion Criteria: - Patient with a contraindication to percutaneous vertebroplasty, such as coagulation disorders, or an allergy or hypersensitivity to any of the products administered during the procedure; - Patient not affiliated to a social security scheme; - Patient participating in another clinical trial during the follow-up period; - Inability to understand information related to the study (linguistic, psychiatric, cognitive reason, etc.).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Vertebroplasty
Patient will undergo a surgery in percutaneous vertebroplasty

Locations

Country Name City State
France Clinique Belharra Bayonne

Sponsors (1)

Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety The main analysis consists of testing the superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety, evaluated on a numerical scale of 0 to 10 10 days
Secondary Pain evaluation Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable 10 days
Secondary Patient satisfaction Evaluation of the patient satisfaction with care, assessed on a 5-level scale (not at all satisfied / somewhat dissatisfied / moderately satisfied / somewhat satisfied / very satisfied) 10 days
Secondary Functional impotence Evaluation of the functional impotence of low back pain by the Quebec score, which includes 20 questions on the ability to undertake daily activities, rated from 0 (no difficulty) to 5 (unable). The score therefore varies from 0 to 100. 10 days
Secondary Consumption of analgesics Evaluation of the consumption of analgesics expressed in mg of morphine equivalent. 10 days
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