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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shanghai 6th People's Hospital
Shanghai 10th People's Hospital
China Medical University, China
Beijing Friendship Hospital
The Second Affiliated Hospital of Chongqing Medical University
Information provided by (Responsible Party):
Gang Sun;Chungen Wu;Maoquan Li;Bo Feng; Hai Tang;ZL Deng, Jinan Military General Hospital
ClinicalTrials.gov Identifier:
NCT01677806
First received: August 23, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Acute Osteoporotic Spinal Fractures
Procedure: Percutaneous vertebroplasty
Other: Conservative therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial

Resource links provided by NLM:


Further study details as provided by Jinan Military General Hospital:

Primary Outcome Measures:
  • VAS score [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • QUALEFFO total score [ Time Frame: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc.


Estimated Enrollment: 140
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Percutaneous vertebroplasty Procedure: Percutaneous vertebroplasty
Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
Active Comparator: Conservative therapy 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).

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677806

Locations
China, Shandong
The Jinan Military General Hospital
Jinan, Shandong, China, 250031
Sponsors and Collaborators
Jinan Military General Hospital
Shanghai 6th People's Hospital
Shanghai 10th People's Hospital
China Medical University, China
Beijing Friendship Hospital
The Second Affiliated Hospital of Chongqing Medical University
Investigators
Principal Investigator: Gang Sun, M.D The Jinan Military General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Gang Sun;Chungen Wu;Maoquan Li;Bo Feng; Hai Tang;ZL Deng, Clinical Professor, Jinan Military General Hospital
ClinicalTrials.gov Identifier: NCT01677806     History of Changes
Other Study ID Numbers: JNMGH20120821
Study First Received: August 23, 2012
Last Updated: March 11, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Jinan Military General Hospital:
Percutaneous vertebroplasty

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on July 23, 2014