Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03451305
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.9
• Patients Per Site Per Month: 7.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Compression Fracture Spine; Osteoporosis Fracture	Other: Pillow	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients with single level osteoporotic compression fracturePatients 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: Jan 23, 2018
• Anticipated Primary Completion Date: May 23, 2019
• Anticipated Study Completion Date: May 23, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Sagittal plane contour [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	112

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.

• Responsible Party: vghtpe user, Department of orthopedics, Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT03451305
• Other Study ID Numbers: 2017-05-005C
• First Posted: Mar 1, 2018
• Last Update Posted: Mar 1, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by vghtpe user, Department of orthopedics, Taipei Veterans General Hospital, Taiwan: Compression fracture, postural reduction, vertebroplasty
• Additional relevant MeSH terms: Osteoporosis; Fractures, Bone; Spinal Fractures; Fractures, Compression; Osteoporotic Fractures

Study Results

No Results Posted as of Mar 1, 2018