NCT03451305

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.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 23, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

February 7, 2018

Last Update Submit

February 23, 2018

Conditions

Compression Fracture SpineOsteoporosis Fracture

Keywords

Compression fracture, postural reduction, vertebroplasty

Outcome Measures

Primary Outcomes (1)

  • Sagittal plane contour

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

    6 months of post-operative follow up

Secondary Outcomes (1)

  • Functional outcome

    6 months of post-operative follow up

Study Arms (2)

Pillow group

EXPERIMENTAL

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.

Other: Pillow

No pillow group

NO INTERVENTION

No intervention was given in this group before surgery.

Interventions

PillowOTHER

A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position

Pillow group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single level osteoporotic compression fracture of thoracic and lumbar spine

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 14563813BACKGROUND

  • 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.

    PMID: 24462536BACKGROUND

  • 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.

    PMID: 16575333RESULT

MeSH Terms

Conditions

Osteoporotic FracturesFractures, Compression

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Central Study Contacts

Ming-Chau Chang, M.D.

CONTACT

886-2-28717557mcchang@vghtpe.gov.tw

Yu-Cheng Yao, M.D.

CONTACT

886-2-28717557orthycyao@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with single level osteoporotic compression fracture
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of orthopedics

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 1, 2018

Study Start

January 23, 2018

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

TW(1)