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Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation

U

University Hospital Bonn (UKB)

Status

Unknown

Conditions

Lung Function
Osteoporotic Vertebral Compression Fractures

Treatments

Procedure: Radiofrequency Kyphoplasty

Study type

Observational

Funder types

Other

Identifiers

NCT01609712
B-O-P-LF-02 (Other Identifier)
B-O-P-LF-01

Details and patient eligibility

About

Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume.

Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture.

In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • over 50 years
  • VAS over 49, ODI over 29
  • radiographic evidence of A 1.1, 1.2, 1.3 fractures
  • patients mentally capable to sign informed consent

Exclusion criteria

  • high-energy trauma
  • known tumor involvement
  • osteonecrotic fractures
  • burst fractures or pedicle fractures
  • previous surgical treatment for a vertebral body compression fracture
  • patient has paget's disease
  • BMI > 35
  • uncontrolled diabetes HbAc1c > 7%
  • severe cardiopulmonary disease
  • Myelopathy
  • long-time steroid therapy

Trial design

30 participants in 1 patient group

Patient with vertebral compression fracture
Description:
RF kyphoplasty is standard of care in our hospital for patients with osteoporortic compression fractures. We are intersetd, if it also can improve the lung function.
Treatment:
Procedure: Radiofrequency Kyphoplasty

Trial contacts and locations

1

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Central trial contact

Robert Pflugmacher, M.D.; Rahel Bornemann

Data sourced from clinicaltrials.gov

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