RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl). - Focal tenderness on the level of the vertebral fracture. - Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence. - Osteoporotic Fractures type 1-4. - Fracture involves no more than 4 vertebral body levels. - Vertebroplasty can be done in one session. - Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60. - Able to understand and read Danish. - Written willing to sign a consent form. - Relevant pain started ≤ 3 months prior to enrollment. Who Should NOT Join This Trial: - Contra-indications for spine surgery. - Platelets \< 30 mia/l. - Osteoporotic Fractures type 5 and Pincer-type. - Complete collapse of the vertebral body precluding insertion of needle. - Presence of neurologic deficit. - Contraindications for MRI scanning. - Psychological or psychiatric disorder that is expected to interfere with compliance. - Active malignancy. - Mini Mental State Examination (MMSE) test score below 24. - History of chronic back pain requiring ongoing opiate use. - Systemic or local infection of the spine. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl). * Focal tenderness on the level of the vertebral fracture. * Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence. * Osteoporotic Fractures type 1-4. * Fracture involves no more than 4 vertebral body levels. * Vertebroplasty can be done in one session. * Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60. * Able to understand and read Danish. * Written informed consent. * Relevant pain started ≤ 3 months prior to enrollment. Exclusion Criteria: * Contra-indications for spine surgery. * Platelets \< 30 mia/l. * Osteoporotic Fractures type 5 and Pincer-type. * Complete collapse of the vertebral body precluding insertion of needle. * Presence of neurologic deficit. * Contraindications for MRI scanning. * Psychological or psychiatric disorder that is expected to interfere with compliance. * Active malignancy. * Mini Mental State Examination (MMSE) test score below 24. * History of chronic back pain requiring ongoing opiate use. * Systemic or local infection of the spine.

Treatments Being Tested

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