Osteoporotic Vertebral Compression FracturesNCT01609712
Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
An observational study of Osteoporotic Vertebral Compression Fractures and Lung Function, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures, Lung Function
- What is being tested?
- Radiofrequency Kyphoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoporotic compression fractures, mostly elderly females
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- BMI > 35
- uncontrolled diabetes HbAc1c > 7%
- severe cardiopulmonary disease
- Myelopathy
- long-time steroid therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Orthopädie und Unfallchirurgie Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Robert Pflugmacher, M.D., +49-151-58233263, robert.pflugmacher@googlemail.com
About this study
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.
- Being tested
- Radiofrequency Kyphoplasty
- Keywords
- Improvement of lung function (FEV1, PEF), Visual Analog Scale, Oswestry Disability Index, Radiographs pre and post Op
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency KyphoplastyProcedure or surgery
Also called RF-Kyphoplasty
Radiofrequency kyphoplasty is a new form of surgical treatment. It injects an ultrahigh viscosity cement into the fractured vertebral body, using radiofrequency to achieve the proper consistency of the cement. This ultrahigh viscosity cement is designed to first restore proper height and alignment to the fractured vertebra and then to stabilize the fracture, thereby preventing further intravertebral motion and reducing pain.
The RF-Kyphoplasty is standard of care in our hospital. It is FDA and CE approved.
| Study group | Role | What they receive |
|---|---|---|
| Patient with vertebral compression fracture | 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. Receives: Procedure: Radiofrequency Kyphoplasty |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral Compression FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Pflugmacher, University Hospital, Bonn
- Investigators
- Robert Pflugmacher, M.D., Principal investigator, Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609712
- Sponsor's protocol ID
- B-O-P-LF-01
- Other IDs
- B-O-P-LF-02
- Status last verified
- Jun 2012
- First submitted
- 29 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
- ClinicalTrials.gov ID
- NCT01609712
- Acronym / sponsor ID
- B-O-P-LF-01
- Keywords
- Improvement of lung function (FEV1, PEF), Visual Analog Scale, Oswestry Disability Index, Radiographs pre and post Op
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- May 2012
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with vertebral compression fracture | – | Procedure: Radiofrequency KyphoplastyRF 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoporotic compression fractures, mostly elderly females
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- high-energy trauma
- known tumor involvement
- osteonecrotic fractures
- burst fractures or pedicle fractures
- previous surgical treatment for a vertebral body compression fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency KyphoplastyAlso: RF-KyphoplastyRadiofrequency kyphoplasty is a new form of surgical treatment. It injects an ultrahigh viscosity cement into the fractured vertebral body, using radiofrequency to achieve the proper consistency of the cement. This ultrahigh viscosity cement is designed to first restore proper height and alignment to the fractured vertebra and then to stabilize the fracture, thereby preventing further intravertebral motion and reducing pain. The RF-Kyphoplasty is standard of care in our hospital. It is FDA and CE approved. | Procedure or surgery | Patient with vertebral compression fracture |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Pflugmacher, M.D. principal investigator
Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Vertebral Compression Fractures and Lung Function, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Pflugmacher, M.D. (+4915158233263, robert.pflugmacher@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.