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

NCT06776003 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • Osteoporotic Vertebral Compression Fractures

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.

Sponsors & Collaborators

  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Mikkel Ø Andersen, Prof, MD · Spine Centre of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06776003 on ClinicalTrials.gov