Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

December 2, 2017 updated by: Liu Haiying, Peking University People's Hospital

Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial

Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.

Study Overview

Detailed Description

This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • vertebral compression fracture on spine radiograph (minimum 15% height loss)
  • level of fracture at Th5 or lower; back pain for 6 weeks or less
  • focal tenderness at fracture level on physical examination
  • bone oedema of vertebral fracture on MRI
  • decreased bone density (T scores ≤-1)

Exclusion Criteria:

  • severe cardiopulmonary comorbidity
  • suspected underlying malignant disease
  • radicular syndrome
  • spinal-cord compression syndrome
  • contraindication for radiography exam

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: grade 1
percutaneous vertebroplasty
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
ACTIVE_COMPARATOR: grade 2
conservative treatment
complete on bed with prevention of complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of pain relief
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
World Health Organization pain classification
1 day, 1 week, 1 month, 3 months, 6 months, and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
1 day, 1 week, 1 month, 3 months, 6 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (ACTUAL)

December 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 2, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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