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Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

Primary Purpose

Compression Fracture Spine, Osteoporosis Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pillow
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compression Fracture Spine focused on measuring Compression fracture, postural reduction, vertebroplasty

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Single level osteoporotic compression fracture of thoracic and lumbar spine

Exclusion Criteria:

  • Can't tolerate the postural reduction by pillow
  • Pathological spine fracture caused by tumor, infection.
  • Multiple spine fractures
  • Patient presented with neurological. deficits

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pillow group

No pillow group

Arm Description

Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day.

No intervention was given in this group before surgery.

Outcomes

Primary Outcome Measures

Sagittal plane contour
Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs

Secondary Outcome Measures

Functional outcome
Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain

Full Information

First Posted
February 7, 2018
Last Updated
February 23, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03451305
Brief Title
Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture
Official Title
Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
May 23, 2019 (Anticipated)
Study Completion Date
May 23, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compression Fracture Spine, Osteoporosis Fracture
Keywords
Compression fracture, postural reduction, vertebroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with single level osteoporotic compression fracture
Masking
Investigator
Masking Description
Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the international or control group. The attending surgeons and patients were blinded before the surgery.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pillow group
Arm Type
Experimental
Arm Description
Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day.
Arm Title
No pillow group
Arm Type
No Intervention
Arm Description
No intervention was given in this group before surgery.
Intervention Type
Other
Intervention Name(s)
Pillow
Intervention Description
A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position
Primary Outcome Measure Information:
Title
Sagittal plane contour
Description
Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs
Time Frame
6 months of post-operative follow up
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain
Time Frame
6 months of post-operative follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Single level osteoporotic compression fracture of thoracic and lumbar spine Exclusion Criteria: Can't tolerate the postural reduction by pillow Pathological spine fracture caused by tumor, infection. Multiple spine fractures Patient presented with neurological. deficits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Chau Chang, M.D.
Phone
886-2-28717557
Ext
9
Email
mcchang@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Cheng Yao, M.D.
Phone
886-2-28717557
Ext
9
Email
orthycyao@gmail.com
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Chau Chang, M.D.
Phone
886-2-28717557
Ext
9
Email
mcchang@vghtpe.gov.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
14563813
Citation
Rao RD, Singrakhia MD. Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Joint Surg Am. 2003 Oct;85(10):2010-22. No abstract available.
Results Reference
background
PubMed Identifier
24462536
Citation
Lee JH, Lee DO, Lee JH, Lee HS. Comparison of radiological and clinical results of balloon kyphoplasty according to anterior height loss in the osteoporotic vertebral fracture. Spine J. 2014 Oct 1;14(10):2281-9. doi: 10.1016/j.spinee.2014.01.028. Epub 2014 Jan 23.
Results Reference
background
PubMed Identifier
16575333
Citation
Chin DK, Kim YS, Cho YE, Shin JJ. Efficacy of postural reduction in osteoporotic vertebral compression fractures followed by percutaneous vertebroplasty. Neurosurgery. 2006 Apr;58(4):695-700; discussion 695-700. doi: 10.1227/01.NEU.0000204313.36531.79.
Results Reference
result

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Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

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