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RECRUITING
NCT06776003
NA

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

Sponsor: Spine Centre of Southern Denmark

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-02-20

Completion Date

2026-12

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

PROCEDURE

Vertebroplasty

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

PROCEDURE

Sham 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