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Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

T

Taipei Veterans General Hospital

Status

Unknown

Conditions

Compression Fracture Spine
Osteoporosis Fracture

Treatments

Other: Pillow

Study type

Interventional

Funder types

Other

Identifiers

NCT03451305
2017-05-005C

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

120 participants in 2 patient groups

Pillow group
Experimental group
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.
Treatment:
Other: Pillow
No pillow group
No Intervention group
Description:
No intervention was given in this group before surgery.

Trial contacts and locations

1

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Central trial contact

Yu-Cheng Yao, M.D.; Ming-Chau Chang, M.D.

Data sourced from clinicaltrials.gov

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