Safety and Efficacy Study of Percutaneous Vertebroplasty for Painful Acute Osteoporotic Spine Fractures

Overview

Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management has not been successful or for those who are at risk for developing complications due to long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham control intervention failed to show an advantage of vertebroplasty over placebo for participants with acute, subacute, and chronic fractures or severe pain. In the third RCT, PVP compared to optimal conservative treatment showed significant immediate postoperative pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues, this study is initiated to compare PVP with conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP increases the incidence of new compression fractures in adjacent vertebrae.

Full Title of Study: “Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Detailed Description

Osteoporotic vertebral fractures (OVCFs) are common in the elderly population, with an estimated 1.4 million new fractures occurring every year worldwide. Patients may present with pain and frequently require hospital admission for analgesia, bed rest, and physical support (bracing). While their back pain may last for 6-12 weeks, complications such as pneumonia, decubitus ulcers, venous thromboembolism, and even death may occur. Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management has not been successful or for those who are at risk for developing complications due to long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP have been published with conflicting results. So this study is to compare PVP with conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP increases the incidence of new compression fractures in adjacent vertebrae.

This study is a multicenter randomized controlled trial (RCT), Participants in this study will be allocated randomly to PVP or conservative treatment.All Participants will be asked to fill out standard questionnaires to provide clinical information at baseline (the day of randomization), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment. Cross-over will not be offered before 12 months after randomization. All standard questionnaires (except the 1-day questionnaire) consist of the VAS score, Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), EQ-5D, and Roland-Morris Disability (RMD) Questionnaire. Furthermore,additional questions about pain treatment, hospital stay, outpatient visits,medical aids, and medical costs will be completed with the help of a nurse practitioner.

Interventions

  • Procedure: Percutaneous vertebroplasty
    • Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
  • Other: Conservative therapy
    • Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients’ needs, including analgesia, bed rest, and physical support (bracing).

Arms, Groups and Cohorts

  • Experimental: Percutaneous vertebroplasty
  • Active Comparator: Conservative therapy

Clinical Trial Outcome Measures

Primary Measures

  • VAS score
    • Time Frame: at 1 month
    • Pain assessment is based on the VAS scale, a scale from 0 (no pain) to 10 (worst pain ever), for which a decrease of 3.0 or more points from baseline is considered to be clinically significant pain relief.

Secondary Measures

  • QUALEFFO total score
    • Time Frame: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
    • QUALEFFO total score is measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). This questionnaire consists of 41 items and includes five domains: pain, physical function, social function, general health perception, and mental function.
  • ED-5Q score
    • Time Frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
    • EQ-5D is a standardized instrument utilized as a measure of health-related quality of life outcomes. Furthermore, EQ-5D is one of a few measures recommended for use in cost-effectiveness analyses by the Washington Panel on Cost Effectiveness in Health & Medicine as well as in National guidelines in economic evaluation.
  • RMD score
    • Time Frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
    • The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain. RMD scores range from 0 to 24, with higher numbers indicating worse physical functioning.
  • New vertebral fractures
    • Time Frame: at baseline, 1 month, 3 months, and 1 year.
    • New vertebral fractures are defined as a decrease (compared with baseline radiographs) of 20% or more, and at least 4 mm, in any of the three vertebral heights (anterior, middle, or posterior) on follow-up.
  • Total medical costs
    • Time Frame: at 1-month, 12-month
    • This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc.

Participating in This Clinical Trial

Inclusion Criteria

  • 50 Years and older
  • have a confirmed diagnosis of osteoporosis or osteopenia.
  • acute, painful OVCFs from T4-L5
  • clinical onset < 6 weeks
  • vertebral compression fracture on spine radiograph (minimum 15% height loss)
  • Visual Analogue Scale [VAS] score ≥ 4 for pain

Exclusion Criteria

  • severe cardio-pulmonary condition
  • untreatable coagulopathy
  • active local or systemic infection
  • current malignancy, or radicular or caudal compression syndrome

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jinan Military General Hospital
  • Collaborator
    • Shanghai 6th People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gang Sun;Chungen Wu;Maoquan Li;Bo Feng; Hai Tang;ZL Deng, Clinical Professor – Jinan Military General Hospital
  • Overall Official(s)
    • Gang Sun, M.D, Principal Investigator, The Jinan Military General Hospital

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