Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

Osteoporosis Fracture Clinical Trial

Official title:

Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03451305
• Other study ID #: 2017-05-005C
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2018
• Last updated: February 23, 2018
• Start date: January 23, 2018
• Est. completion date: May 23, 2019

Study information

• Verified date: February 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ming-Chau Chang, M.D.
• Phone: 886-2-28717557
• Email: mcchang[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 23, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compression Fracture Spine
• Fractures, Bone
• Fractures, Compression
• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures
• Spinal Fractures

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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-A(10):2010-22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional outcome	Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain	6 months of post-operative follow up