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Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

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ClinicalTrials.gov Identifier: NCT03451305
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Compression Fracture Spine Osteoporosis Fracture Other: Pillow Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with single level osteoporotic compression fracture
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : May 23, 2019
Estimated Study Completion Date : May 23, 2019

Resource links provided by the National Library of Medicine


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

No Intervention: No pillow group
No intervention was given in this group before surgery.



Primary Outcome Measures :
  1. Sagittal plane contour [ Time Frame: 6 months of post-operative follow up ]
    Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs


Secondary Outcome Measures :
  1. Functional outcome [ Time Frame: 6 months of post-operative follow up ]
    Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451305


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

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Ming-Chau Chang, M.D.    886-2-28717557 ext 9    mcchang@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

Publications of Results:
Other Publications:
Responsible Party: vghtpe user, Department of orthopedics, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03451305     History of Changes
Other Study ID Numbers: 2017-05-005C
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Compression fracture, postural reduction, vertebroplasty

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Spinal Fractures
Fractures, Compression
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries