Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty.

The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures

NCT01537770

Osteoporotic Fractures

COMPLETED NA

A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures

NCT01200277

Osteoporosis Vertebral Fracture

COMPLETED PHASE3

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

NCT00203554

Pain Osteoporosis Fracture

COMPLETED NA

A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

NCT01963039

Osteoporosis Vertebral Fracture

COMPLETED NA

Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

NCT00279877

Osteoporotic Vertebral Compression Fractures

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study design is a prospective, double-blind, randomized, sham-controlled clinical trial where patients are stratified into either involvement of 1-2 vertebral levels or 3-4 levels and randomized to either vertebroplasty or a sham operation. The trial is designed in accordance with the SPIRIT guidelines.

Patients will be examined in the outpatient clinic at the Center for Spine Surgery and Research, Lillebaelt Hospital, Kolding, Denmark. MRI scans and X-ray images will be performed at the radiology department at the hospital. Experienced neuro-radiologists carry out image analyses.

Spine surgeons who are experienced in PVP will perform the surgical procedures. Anaesthesiologists and spine surgeons are present at the facility in case of complications, following recommendations by the National Health Authority and have the capacity/capability to decompress the spinal canal in case of cement leakage.

Study subjects will be recruited from patients diagnosed with painful x-ray verified vertebral compression fractures in the Region of southern Denmark. The patients will be identified and referred to the trial site by the patients' general practitioner, chiropractor, physiotherapist, or from hospital inpatient and emergency departments in the region of Southern Denmark.

Subjects will initially be stratified into two groups based on the number of OVCFs into 1-2 levels or 3-4 levels. Within each of these two groups, randomization sheets in varying blocks of 8 with an equal number of PVP and sham patients in each block will be generated using software (www.randomizer.org) and will be placed in numbered, opaque, sealed envelopes. Treatment group assignment will be performed by a scrub nurse in the surgical theatre after the patient is draped but prior to skin incision. Throughout the trial, only the surgeon and the OR-nurse will have knowledge of the treatment assignment. The patient and all assessors remain blinded to the treatment group throughout the study.

During hospitalization, perioperative data on operation time, theater time and complications will be collected from the operating room staff during surgery. Upon discharge, length of stay will be recorded for each patient. After discharge, all visits to the outpatient clinic, either to the surgeon, nurse or physiotherapist as well as phone calls with questions regarding their procedure to the surgical nurse and time spent will be recorded.

Patients will be seen in the clinic for evaluation at 4, 12, and 52 weeks after treatment. MRI and full-standing anteroposterior and lateral radiographs will be taken at the 12-week follow-up time point. This will allow for identification of any healing at the index level as well as any new-onset OVCFs.

Treatment effectiveness analyses of the randomized trial data will performed on an intent-to-treat basis. Enrolled patients and outcome assessors will remain blinded for the duration of the trial. The 12-week follow-up will be the primary endpoint.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporotic Fractures Vertebral Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vertebroplasty

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

Group Type ACTIVE_COMPARATOR

Vertebroplasty

Intervention Type PROCEDURE

PVP

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.

Group Type SHAM_COMPARATOR

Sham Vertebroplasty

Intervention Type PROCEDURE

Sham PVP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vertebroplasty

PVP

Intervention Type PROCEDURE

Sham Vertebroplasty

Sham PVP

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
* PVP 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No