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Completed

NCT Number: NCT02902250

The Comparative Study About the Effect of Vertebral Body Decompression Procedure

The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design

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Key information

Conditions

Osteoporotic Vertebral Compression Fracture Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • osteoporotic vertebral compression fracture

Exclusion criteria

  • malignancy or inflammatory disease
  • severe pain in other joints
  • coagulopathy
  • an inappropriate person considered by investigator

Treatment and study plan

Decompression

Procedure

vertebral body decompression in compression fracture

Conservative treatment

Procedure

Conservative Treatment in vertebral compression fracture

Primary outcomes

  1. Visual Analog Pain Scale

    Time frame: until 3 months after procedure

    Pain status

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: until 3 months after procedure

    Health status

  2. EQ5D-5L

    Time frame: until 3 months after procedure

    Quality of Life

  3. Leed Dyspepsia Questionnaire

    Time frame: until 3 months after procedure

    Abdominal discomfort d/t medication and injection

  4. Radiographic outcome

    Time frame: until 3 months after procedure

    Compression rate

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2016
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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