One or Two Traumatic Vertebral FracturesPhase 4TRAUMAA3B1C1NCT00749229
Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation
A Phase 4 study testing balloon kyphoplasty in people with One or Two Traumatic Vertebral Fractures and Located Between T11 and L5, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One or Two Traumatic Vertebral Fractures, Located Between T11 and L5, Balloon Kyphoplasty
- What is being tested?
- balloon kyphoplasty
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Mar 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure)
- Patient must have signed the consent form
- Male or female patient aged 18 or over
- One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle > 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression
- Fracture with or without neurological difficulties
- Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure.
Who cannot join
- Non- traumatic, malignant or osteoporotic vertebral fractures
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
- More than two recent vertebral fractures
- Current infection
- Impossibility to perform the percutaneous approach of the vertebra to treat.
Show all 13Show fewer
- Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat.
- Vertebral fracture with loss of 90%or more of the vertebral body height
- Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
- Evolutive cardiac disease nonreactive to medical treatment
- Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.
- Pregnant or breast feeding women
- Patient not affiliated to social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Study on the Feasibility and Reliability of 'Open' Balloon Kyphoplasty in Types A3.2, A3.3, B1 and C1 MAGERL Classification Vertebral Fractures(STIC 4)
Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.
Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.
Read the detailed description
Patients with traumatic vertebral fractures type A3.2, A3.3, B1 and C1 of the MAGERL classification will be enrolled in this open study. They will be operated on in emergency to perform spinal canal decompression, fracture reduction and posterior fixation using fixation plates with pedicular screws combined with bone graft.
During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength.Patients will be followed up for one year.
Expected advantages of this management compared the conventional two session surgery include the following:
- decreased morbidity due to suppression of the anterior surgery
- improve final spine alignment and vertebral Kyphotic angle avoiding the loss in kyphotic angle which often occurs between the posterior and anterior surgery with the conventional two session surgery.
- Being tested
- balloon kyphoplasty
- Keywords
- Traumatic vertebral fracture, Balloon Kyphoplasty, type A3.2, or A3.3 or B1 or C1 in the MAGERL CLASSIFICATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon kyphoplastyDevice
During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Balloon kyphoplasty Receives: Device: balloon kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements
Measured: 1 year
Secondary outcomes (10)
Pain evaluation using a visual analogic scale
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
EIFEL questionnaire for back pain evaluation
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Quality of life evaluation (SF 12).
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle.
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra.
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Number of new vertebral fractures occurring during the one year follow-up period.
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Cost evaluation in a sample of 10% of patients randomly selected including the following costs : o Intervention cost.o Medical treatment costs o Consultation costs. o Hospitalization cost o Complication costs
Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts tomodensitometry (TDM) on the sagittal level : lateral right, median and lateral left
Measured: preoperative, at J6 and at J360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: the number of patients recruited at present is sufficient for analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One or Two Traumatic Vertebral FracturesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Denis LAREDO, M.D.,PR., Principal investigator, AP/HP Assistance Publique-Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749229
- Sponsor's protocol ID
- P060109
- Acronym
- TRAUMAA3B1C1
- Status last verified
- Dec 2014
- First submitted
- 8 Sep 2008
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Feasibility and Reliability of 'Open' Balloon Kyphoplasty in Types A3.2, A3.3, B1 and C1 MAGERL Classification Vertebral Fractures(STIC 4)
- ClinicalTrials.gov ID
- NCT00749229
- Acronym / sponsor ID
- TRAUMAA3B1C1 / P060109
- Keywords
- Traumatic vertebral fracture, Balloon Kyphoplasty, type A3.2, or A3.3 or B1 or C1 in the MAGERL CLASSIFICATION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the number of patients recruited at present is sufficient for analysis.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Dec 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Sep 2008 (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.
Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.
Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.
Detailed description
Patients with traumatic vertebral fractures type A3.2, A3.3, B1 and C1 of the MAGERL classification will be enrolled in this open study. They will be operated on in emergency to perform spinal canal decompression, fracture reduction and posterior fixation using fixation plates with pedicular screws combined with bone graft.
During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength.Patients will be followed up for one year.
Expected advantages of this management compared the conventional two session surgery include the following:
- decreased morbidity due to suppression of the anterior surgery
- improve final spine alignment and vertebral Kyphotic angle avoiding the loss in kyphotic angle which often occurs between the posterior and anterior surgery with the conventional two session surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: balloon kyphoplastyBalloon kyphoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure)
- Patient must have signed the consent form
- Male or female patient aged 18 or over
- One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle > 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression
- Fracture with or without neurological difficulties
Key exclusion criteria (13 listed)
- Non- traumatic, malignant or osteoporotic vertebral fractures
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
- More than two recent vertebral fractures
- Current infection
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 |
|---|---|---|
| balloon kyphoplastyDuring the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength | Device | 1 |
Primary outcome
Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements
Time frame: 1 year
10 secondary outcomes
Pain evaluation using a visual analogic scale
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
EIFEL questionnaire for back pain evaluation
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Quality of life evaluation (SF 12).
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle.
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra.
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Number of new vertebral fractures occurring during the one year follow-up period.
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Cost evaluation in a sample of 10% of patients randomly selected including the following costs : o Intervention cost.o Medical treatment costs o Consultation costs. o Hospitalization cost o Complication costs
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts tomodensitometry (TDM) on the sagittal level : lateral right, median and lateral left
Time frame: preoperative, at J6 and at J360
Results and safety
The study was stopped early (reason given: the number of patients recruited at present is sufficient for analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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.
Jean-Denis LAREDO, M.D.,PR. principal investigator
AP/HP Assistance Publique-Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing balloon kyphoplasty in people with One or Two Traumatic Vertebral Fractures and Located Between T11 and L5, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 4 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the number of patients recruited at present is sufficient for analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements (time frame: 1 year). 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 4 Jan 2017.