Interest of the Patient Management by Improved Recovery After Surgery in Percutaneous Vertebroplasty

NCT04453163 | Completed

• 1 other identifier: 2020-A00600-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vertebral Compression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain evaluation

  10 days

• Patient satisfaction

  10 days

• Functional impotence

  10 days

• Consumption of analgesics

  10 days

Study Arms (2)

RAAC program

EXPERIMENTAL

If the patient is under the "RAAC" group, he/she will then be received in consultation by a RAAC specialist nurse, between the anesthesia / radiology consultation and the intervention. This RAAC nurse will explain the procedure and show him/her an information video on vertebroplasty. Information about managing anxiety and pain will also be provided. In addition, the day after the patient leaves the clinic, the RAAC nurse will call him/her to inquire.

Procedure: Vertebroplasty

Standard management program

OTHER

If the patient is under the "control" group, he/she will be taken care of according to the standard protocol after a surgery in percutaneous vertebroplasty. The patient will not have a consultation with the specialized nurse.

Procedure: Vertebroplasty

Interventions

Vertebroplasty PROCEDURE

Patient will undergo a surgery in percutaneous vertebroplasty

RAAC program; Standard management program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique Belharra

Bayonne, France

Location

MeSH Terms

Interventions

Vertebroplasty

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: November 17, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)