Thoracolumbar SpineKIPHONCT02085811
Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine
An observational study of Thoracolumbar Spine, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures. Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracolumbar Spine
- What is being tested?
- radiography standard
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone kyphoplasty
Who may be able to join
- Men or women aged at least 18;
- who underwent Kyphoplasty between T11 and L5,
- Patients who had Kyphoplasty at a single level without associated surgery,
- Magerl type-A fracture.
- Non-tumoral and non-osteoporotic cause.
Who cannot join
- Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
- Osteoporotic vertebral fracture
- Association with other post-traumatic fractures.
- History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
- Pregnant or breast-feeding women
- Patients not covered by national health insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de DIJON
Dijon, 21079
Frederic RICOLFI, 3.80.29.37.44 ext. +33, frederic.ricolfi@chu-dijon.fr
Pierre THOUANT, 3.80.29.37.44 ext. +33, pierre.thouant@chu-dijon.fr
About this study
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.
Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.
An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.
The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.
- Conditions
- Thoracolumbar Spine
- Being tested
- radiography standard
- Keywords
- Kyphoplasty, at a single level, (between T11 and L5), associated surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiography standardOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: radiography standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Spinal kyphosis angle
Measured: Between the post-operative period (D1) and a minimum of one year of follow-up
Secondary outcomes (4)
Evaluation of pain (VAS)
Measured: At least 1 year after the kyphoplasty
Number of new vertebral fractures
Measured: At least 1 year after the kyphoplasty
Evaluation of quality of life (OSWESTRY and EIFEL)
Measured: At least 1 year after the kyphoplasty
Evolution of the regional angle of vertebral kyphosis
Measured: At least 1 year after the kyphoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracolumbar SpineStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085811
- Sponsor's protocol ID
- THOUANT-RICOLFI AOI 2012
- Acronym
- KIPHO
- Status last verified
- Jun 2013
- First submitted
- 5 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine
- ClinicalTrials.gov ID
- NCT02085811
- Acronym / sponsor ID
- KIPHO / THOUANT-RICOLFI AOI 2012
- Conditions
- Thoracolumbar Spine
- Keywords
- Kyphoplasty, at a single level, (between T11 and L5), associated surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 13 Mar 2014 (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.
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.
Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.
An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.
The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: radiography standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone kyphoplasty
Key inclusion criteria (5 listed)
- Men or women aged at least 18;
- who underwent Kyphoplasty between T11 and L5,
- Patients who had Kyphoplasty at a single level without associated surgery,
- Magerl type-A fracture.
- Non-tumoral and non-osteoporotic cause.
Key exclusion criteria (6 listed)
- Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
- Osteoporotic vertebral fracture
- Association with other post-traumatic fractures.
- History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
- Pregnant or breast-feeding women
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 |
|---|---|---|
| radiography standard | Other | Patients |
Primary outcome
Measure of Spinal kyphosis angle
Time frame: Between the post-operative period (D1) and a minimum of one year of follow-up
4 secondary outcomes
Evaluation of pain (VAS)
Time frame: At least 1 year after the kyphoplasty
Number of new vertebral fractures
Time frame: At least 1 year after the kyphoplasty
Evaluation of quality of life (OSWESTRY and EIFEL)
Time frame: At least 1 year after the kyphoplasty
Evolution of the regional angle of vertebral kyphosis
Time frame: At least 1 year after the kyphoplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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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.
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 Thoracolumbar Spine, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 inclusion and 6 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 13 Mar 2014. 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 France. 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 Frederic RICOLFI (3.80.29.37.44 ext. +33, frederic.ricolfi@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Spinal kyphosis angle (time frame: Between the post-operative period (D1) and a minimum of one year of follow-up). It is what the study was designed to measure, not a finding.
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 13 Mar 2014.