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

• Conditions: Osteoporotic Vertebral Compression Fractures; Lung Function
• Interventions: Procedure: Radiofrequency Kyphoplasty

• Registration Number: NCT01609712
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-31
• Status Verified: 2012-06
• Study First Posted: 2012-06-01
• Last Update Submitted: 2012-06-03
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with vertebral compression fracture	Radiofrequency Kyphoplasty	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.

Trial Locations

Locations (1)

Orthopädie und Unfallchirurgie Universitätsklinikum Bonn; 🇩🇪 Bonn, NRW, Germany