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. 2024 Nov 30;19(1):813.
doi: 10.1186/s13018-024-05301-x.

Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2

Mikkel Ø Andersen  1   2 , Andreas K Andresen  3   4 , Jan Hartvigsen  5   6 , A Pernille Hermann  7   8 , Jan Sørensen  9 , Leah Y Carreon  3   4
Affiliations

Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2

Mikkel Ø Andersen et al. J Orthop Surg Res. .

Abstract

Background: One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients' daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing. Vertebral augmentation, also known as vertebroplasty, has been used during the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for its efficacy is weak. We describe a double-blind randomized sham-controlled clinical trial to assess the impact of vertebroplasty on self-reported clinical outcomes in patients with painful osteoporotic vertebral compression fractures and vertebral oedema.

Methods: Two hundred and forty patients with painful osteoporotic vertebral fractures and MRI verified oedema will be randomized in a prospective, double-blind, single-center, clinical trial to either vertebroplasty or a sham procedure, with the possibility of crossover 12 weeks after randomization and operation. The primary outcome will be difference in self-reported pain 12 weeks after treatment between the vertebroplasty and sham group. Secondary outcomes will be patient-reported disability, health-related quality of life, societal costs of treatment and complications. Analysis will be based on intention-to-treat. Repeated measures ANCOVA with baseline ODI, Numerical Pain Rating Scale, EQ-5D-5 L, and number of levels involved as co-variates will be performed.

Discussion: With an aging population, the prevalence of osteoporosis and related complications such as vertebral compression fractures is expected to increase. Therefore, there is a growing need for evidence-based fracture treatments. This study fills a gap in the evidence base for treatment of painful osteoporotic vertebral fractures and will likely influence future treatment guidelines.

Trial registration: The study has been evaluated and approved by the Regional Committees on Health Research for Southern Denmark October 9 2023 (Projekt-ID S-20230058) and the Danish Data Protection Agency 23/40,938. The protocol has been registered at ClinicalTrials.gov with trial registration number NCT06141187 November 21, 2023.

Keywords: Double blind; Pain; Randomized; Sham-controlled; Vertebroplasty.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study will be performed according to the Declaration of Helsinki and the Danish Code of Conduct for Research Integrity. The study has been approved by the Regional Committees on Health Research for Southern Denmark project-ID S-20230058. Further the project has been submitted to and approved by the Region of Southern Denmark and listed in the internal record. Permission from the Institutional Review Board of the Spine Centre of Southern Denmark has been obtained, journal no. 02/2023. Participation in the study is completely voluntary and can only take place after receiving both oral and written information about the study and signing a written consent. Patient information adheres to format requirements from the health research ethics committees and EU legislation. At any time during the study, the participants can withdraw their consent, and this will not affect the right to any current or future treatment. The participants are entitled to bring a member of the family or a friend to the informative interview and will be given several days from study information by phone and written information send by mail to consider participation. The informed consent form will be signed by all participating patients and stored at the Spine Surgery and Research unit, Kolding. A digital copy of the form will be added to the electronic patient records accessible at sundhed.dk. Consent for publication: A copy of the consent form that patients need to sign for study participation, along with a lay summary of the protocol, can be found on the following website: Permission to extract and publish data from hospital records will be obtained from the patients. Consent to use patient-reported information from the DaneSpine database is obtained electronically prior to patients completing the questionnaires. Patients who do not consent will not be included in the trial. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences following guidance from the SPIRIT guidelines. Trial status: Protocol 101528 version 3.1, date 02.10.23. Recruitment initiated 01.01.2024. Recruitment expected completed 31.12.2028. Competing interests: The authors declare no competing interests.

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