RecruitingNot ApplicableNCT06776003

Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture

Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial


Sponsor

Spine Centre of Southern Denmark

Enrollment

64 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis. The focus of the study is on the physical activity and mobility of participants. The main questions the trial aims to answer are: * Does vertebroplasty lead to increased physical activity as measured by accelerometer? * Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)? * Do physical activity and mobility correlate with pain, disability and quality of life? Researchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility. Participants will * Undergo vertebroplasty or sham procedure * Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery * Answer questionnaires regarding pain, disability and quality of life at regular intervals. The knowledge gained from this can help determine who would benefit from vertebroplasty.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Sham Vertebroplasty and a procedure called Vertebroplasty for people with osteoporotic vertebral compression fractures. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREVertebroplasty

Polymethyl-methacrylate (PMMA) cement is injected slowly into the vertebral body under constant bi-plane fluoroscopy

PROCEDURESham Vertebroplasty

A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.


Locations(1)

Spine Centre of Southern Denmark

Kolding, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06776003


Related Trials