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Status unknownNCT03451305Updated Mar 1, 2018

Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

An interventional study of Pillow in Compression Fracture Spine and Osteoporosis Fracture, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Compression Fracture Spine
  • Osteoporosis Fracture

Keywords

  • Compression fracture, postural reduction, vertebroplasty
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Single level osteoporotic compression fracture of thoracic and lumbar spine

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Pillow group

    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 intervention
    No pillow group

    No intervention was given in this group before surgery.

Interventions

  • OtherPillow

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

05

What researchers measure

Primary outcomes

  1. Sagittal plane contour

    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 outcomes

  1. Functional outcome

    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

06

Study locations

1 of 1 sites recruiting
  • Taipei Veterans General Hospital
    Taipei, 112, Taiwan
    Recruiting
07

References and documents

Publications

  • 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. PubMed 14563813 ↗
  • 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. PubMed 24462536 ↗
  • 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. PubMed 16575333 ↗
08

Registry details

Key details

Study ID
NCT03451305
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
vghtpe user (Department of orthopedics, Taipei Veterans General Hospital, Taiwan) — Principal investigator
First posted
Mar 1, 2018
Start date
Jan 23, 2018
Primary completion
May 23, 2019 (estimated)
Completion
May 23, 2019 (estimated)
Last update
Mar 1, 2018

Study contacts

Ming-Chau Chang, M.D.
Contact
mcchang@vghtpe.gov.tw
886-2-28717557 ext. 9
Yu-Cheng Yao, M.D.
Contact
orthycyao@gmail.com
886-2-28717557 ext. 9

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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