NCT01677806

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

August 23, 2012

Last Update Submit

September 9, 2014

Conditions

Acute Osteoporotic Spinal Fractures

Keywords

Percutaneous vertebroplasty

Outcome Measures

Primary Outcomes (1)

  • VAS score

    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.

    at 1 month

Secondary Outcomes (5)

  • QUALEFFO total score

    at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.

  • ED-5Q score

    at baseline, 1-week, and 1-, 3-, 6-, and 12- month

  • RMD score

    at baseline, 1-week, and 1-, 3-, 6-, and 12- month

  • New vertebral fractures

    at baseline, 1 month, 3 months, and 1 year.

  • Total medical costs

    at 1-month, 12-month

Study Arms (2)

Percutaneous vertebroplasty

EXPERIMENTAL
Procedure: Percutaneous vertebroplasty

Conservative therapy

ACTIVE COMPARATOR
Other: Conservative therapy

Interventions

Percutaneous vertebroplastyPROCEDURE

Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture

Percutaneous vertebroplasty
Conservative therapyOTHER

Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).

Conservative therapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jinan Military General Hospital

Jinan, Shandong, 250031, China

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gang Sun, M.D

    The Jinan Military General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 3, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

CN(1)