Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Pain intensity using the 100-point VAS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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) ≥
- •Able to understand and read Danish.
- •Written informed consent.
- •Relevant pain started ≤ 3 months prior to enrollment.
排除标准
- •- 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
- •History of chronic back pain requiring ongoing opiate use.
- •Systemic or local infection of the spine.
结局指标
主要结局
Pain intensity using the 100-point VAS
时间窗: VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
Self-reported average pain intensity over the previous 24 hours, using the 100-point VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
次要结局
- Patient-reported disability.(Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization)
- Sagittal balance(Recorded at enrolment and 12 months post-randomization)
- Societal costs of treatment(Recorded 1 day at discharge and 12 months post-randomization)
- Health-related quality of life.(Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization)
- Global Perceived Effect scale(Recorded at 4 and 12 weeks, 12 and 24 months post-randomization)