Vertebral FractureAGIL11NCT03617094
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures
A study testing Early percutaneous vertebroplasty (EPV) and Standard Conservative treatment (CT) in people with Vertebral Fracture, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Fracture
- What is being tested?
- Early percutaneous vertebroplasty (EPV) and Standard Conservative treatment (CT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2018to 17 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 50 years
- Fracture localisation : vertebrae from T8 to L5
- Recent fracture (< 10 days, maximum 15 days)
- CT scan showing a fracture of the superior endplate and of the anterior cortex of the vertebral body of type A1 according to the Magerl classification AND vertebral kyphosis deformation < 30°
- Patient affiliated to the French social security system or an equivalent system
- Patient who has signed consent form
Who cannot join
- Multiple level fracture
- Repeated fracture at the same level
- Others peripheral fractures
- Contraindication for percutaneous procedure
- Contraindication for vertebroplasty procedure (pathology with risk of decompensation, coagulation problems, deformation considered by the surgeon to be inaccessible by vertebroplasty procedure, presence of an infected site)
- Contraindication for anasthesia
Show all 15Show fewer
- Methylmethacrylate (MMA) allergy known
- Impossibility to plan the start of the treatment (set up of treatment or carrying out of a vertebroplasty gesture) within a maximum deadline of 15 days after the fracture
- Body Mass Index (BMI) > 31,5
- Progressive local infection
- Progressive local cancer
- Patient presenting cognitive disorder with behavioural disorder which could disturb the treatment
- Non-cooperative patient
- Patient who can not be followed up at Grenoble hospital during the 3 months of the study
- Patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study
The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.
This is a monocentric, randomized, parallel group, prospective and open-label study.
Read the detailed description
In this study, 58 patients with a vertebral fracture no more than 10 days old (with a max of 15 days old) will be enrolled. Treatment will be randomly allocated in 2 groups: Early percutaneous vertebroplasty (EPV group) or standard conservative treatment (corset, CT group). Patients will be followed up during 3 months after treatment. They will receive standard care for a vertebral fracture at the Grenoble-Alpes University Hospital.
Evaluated criteria: Vertebral kyphosis evolution, Pain, Efficacy and Quality of vertebroplasty procedure, Tolerance and observance of the standard treatment, Safety, Physical performance, Quality of life, Autonomy.
- Conditions
- Vertebral Fracture
- Being tested
- Early percutaneous vertebroplasty (EPV), Standard Conservative treatment (CT)
- Keywords
- Vertebral fracture, Early Percutaneous Vertebroplasty, Standard Conservative Treatment, Kyphosis angle
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early percutaneous vertebroplasty (EPV)Device
Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.
Standard Conservative treatment (CT)Device
Treatment consists of using a made-to-measure 3 point thoracolumbar corset,that is worn for 3 months: night and day during the first 6 week period of the treatment, and then only the day for the next 6 week period.
| Study group | Role | What they receive |
|---|---|---|
| Early percutaneous vertebroplasty (EPV) | Experimental | Surgical procedure of percutaneous vertebroplasty. Receives: Device: Early percutaneous vertebroplasty (EPV) |
| Standard Conservative treatment (CT) | Active comparator | Thoracolumbar corset. Receives: Device: Standard Conservative treatment (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
Difference in the kyphotic angle measured at the fracture diagnosis and after 3 months of treatment
Measured: Diagnosis, and after 3 months of treatment
Secondary outcomes (15)
Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups
Pain will be assessed using a Visual Analogic Scale (score from 0 to 10)
Measured: diagnosis, after 24 hours, 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle
Kyphotic angle (KA)
Measured: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height
Anterior vertebral height (HA)
Measured: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio
Vertebral Compression Ratio (AP)
Measured: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle
Regional kyphotic angle (RA)
Measured: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling
Evaluation of the quality of cement filling as poor / acceptable / satisfactory, according to the method described in L.Garnier and col, 2012.
Measured: Immediately post-op
Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment
Number of thoracolumbar corset readjustments carried out during follow up (3 months)
Measured: 3 months
Evaluation of the observance of the treatment by corset (CT arm)
Daily observance report of thoracolumbar corset wear during follow up (3 months)
Measured: 3 months
Comparison of the adverse events during the study between the two groups
Numbers of adverse events (classification : minor, mild, severe)
Measured: 3 months
Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups
Physical performance will be assessed using Short Physical Performance Battery test (SPPB, score from 0 to 12)
Measured: 24 hours and 3 months after treatment
Comparison of the evolution in the autonomy of the patients using ADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups
ADL (Activities of Daily living) questionnaire score
Measured: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the evolution in the autonomy of the patients using IADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups
IADL (Instrumental ADL) questionnaire score
Measured: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the evolution of quality of life using SF-36 questionnaire score (before and after vertebral fracture, and 3 months after treatment) between the two groups
SF-36 (Short Form-36 Health Survey) questionnaire score
Measured: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the evolution of quality of life using QUALEFFO questionnaire (before and after vertebral fracture, and 3 months after treatment) between the two groups
QUALEFFO (Quality of life questionnaire of the European Foundation for Osteoporosis) questionnaire score
Measured: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the number of days of hospitalization between the two groups
Length of hospitalization (days)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start5 Jul 2018
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Mehdi Boudissa, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617094
- Sponsor's protocol ID
- 38RC17.276
- Acronym
- AGIL11
- Status last verified
- Jan 2023
- First submitted
- 28 May 2018
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garnier L, Tonetti J, Bodin A, Vouaillat H, Merloz P, Assaker R, Court C; French Society for Spine Surgery. Kyphoplasty versus vertebroplasty in osteoporotic thoracolumbar spine fractures. Short-term retrospective review of a multicentre cohort of 127 consecutive patients. Orthop Traumatol Surg Res. 2012 Oct;98(6 Suppl):S112-9. doi: 10.1016/j.otsr.2012.03.018. Epub 2012 Aug 28.
PubMed 22939104
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study
- ClinicalTrials.gov ID
- NCT03617094
- Acronym / sponsor ID
- AGIL11 / 38RC17.276
- Conditions
- Vertebral Fracture
- Keywords
- Vertebral fracture, Early Percutaneous Vertebroplasty, Standard Conservative Treatment, Kyphosis angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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 study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.
This is a monocentric, randomized, parallel group, prospective and open-label study.
Detailed description
In this study, 58 patients with a vertebral fracture no more than 10 days old (with a max of 15 days old) will be enrolled. Treatment will be randomly allocated in 2 groups: Early percutaneous vertebroplasty (EPV group) or standard conservative treatment (corset, CT group). Patients will be followed up during 3 months after treatment. They will receive standard care for a vertebral fracture at the Grenoble-Alpes University Hospital.
Evaluated criteria: Vertebral kyphosis evolution, Pain, Efficacy and Quality of vertebroplasty procedure, Tolerance and observance of the standard treatment, Safety, Physical performance, Quality of life, Autonomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early percutaneous vertebroplasty (EPV) | Experimental | Device: Early percutaneous vertebroplasty (EPV)Surgical procedure of percutaneous vertebroplasty. |
| Standard Conservative treatment (CT) | Active comparator | Device: Standard Conservative treatment (CT)Thoracolumbar corset. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 50 years
- Fracture localisation : vertebrae from T8 to L5
- Recent fracture (< 10 days, maximum 15 days)
- CT scan showing a fracture of the superior endplate and of the anterior cortex of the vertebral body of type A1 according to the Magerl classification AND vertebral kyphosis deformation < 30°
- Patient affiliated to the French social security system or an equivalent system
Key exclusion criteria (15 listed)
- Multiple level fracture
- Repeated fracture at the same level
- Others peripheral fractures
- Contraindication for percutaneous procedure
- Contraindication for vertebroplasty procedure (pathology with risk of decompensation, coagulation problems, deformation considered by the surgeon to be inaccessible by vertebroplasty procedure, presence of an infected site)
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 |
|---|---|---|
| Early percutaneous vertebroplasty (EPV)Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia. | Device | Early percutaneous vertebroplasty (EPV) |
| Standard Conservative treatment (CT)Treatment consists of using a made-to-measure 3 point thoracolumbar corset,that is worn for 3 months: night and day during the first 6 week period of the treatment, and then only the day for the next 6 week period. | Device | Standard Conservative treatment (CT) |
Primary outcome
Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
Time frame: Diagnosis, and after 3 months of treatment
Difference in the kyphotic angle measured at the fracture diagnosis and after 3 months of treatment
15 secondary outcomes
Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups
Time frame: diagnosis, after 24 hours, 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle
Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height
Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio
Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle
Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling
Time frame: Immediately post-op
Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment
Time frame: 3 months
Evaluation of the observance of the treatment by corset (CT arm)
Time frame: 3 months
Comparison of the adverse events during the study between the two groups
Time frame: 3 months
Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups
Time frame: 24 hours and 3 months after treatment
Comparison of the evolution in the autonomy of the patients using ADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups
Time frame: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the evolution in the autonomy of the patients using IADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups
Time frame: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the evolution of quality of life using SF-36 questionnaire score (before and after vertebral fracture, and 3 months after treatment) between the two groups
Time frame: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the evolution of quality of life using QUALEFFO questionnaire (before and after vertebral fracture, and 3 months after treatment) between the two groups
Time frame: Diagnosis (before / after fracture), and 3 months after treatment
Comparison of the number of days of hospitalization between the two groups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Background: PubMed 22939104Garnier L, Tonetti J, Bodin A, Vouaillat H, Merloz P, Assaker R, Court C; French Society for Spine Surgery. Kyphoplasty versus vertebroplasty in osteoporotic thoracolumbar spine fractures. Short-term retrospective review of a multicentre cohort of 127 consecutive patients. Orthop Traumatol Surg Res. 2012 Oct;98(6 Suppl):S112-9. doi: 10.1016/j.otsr.2012.03.018. Epub 2012 Aug 28.
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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.
Mehdi Boudissa, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early percutaneous vertebroplasty (EPV) and Standard Conservative treatment (CT) in people with Vertebral Fracture, run by University Hospital, Grenoble 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 15 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: finished, as of the sponsor's last update on 6 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups (time frame: Diagnosis, and after 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617094, which also lists 1 linked publication.
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 6 Jan 2023.