Back to resultsEarly Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures (AGIL11)
Primary Purpose
Vertebral Fracture
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early percutaneous vertebroplasty (EPV)
Standard Conservative treatment (CT)
Sponsored by
About this trial
This is an interventional other trial for Vertebral Fracture focused on measuring Vertebral fracture, Early Percutaneous Vertebroplasty, Standard Conservative Treatment, Kyphosis angle
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University Hospital, Grenoble
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early percutaneous vertebroplasty (EPV)
Standard Conservative treatment (CT)
Arm Description
Surgical procedure of percutaneous vertebroplasty.
Thoracolumbar corset.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle
Kyphotic angle (KA)
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height
Anterior vertebral height (HA)
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio
Vertebral Compression Ratio (AP)
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle
Regional kyphotic angle (RA)
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.
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)
Evaluation of the observance of the treatment by corset (CT arm)
Daily observance report of thoracolumbar corset wear during follow up (3 months)
Comparison of the adverse events during the study between the two groups
Numbers of adverse events (classification : minor, mild, severe)
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)
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
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
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
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
Comparison of the number of days of hospitalization between the two groups
Length of hospitalization (days)
Full Information
NCT ID
NCT03617094
First Posted
May 28, 2018
Last Updated
January 5, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network
1. Study Identification
Unique Protocol Identification Number
NCT03617094
Brief Title
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures
Acronym
AGIL11
Official Title
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
October 17, 2020 (Actual)
Study Completion Date
October 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Fracture
Keywords
Vertebral fracture, Early Percutaneous Vertebroplasty, Standard Conservative Treatment, Kyphosis angle
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early percutaneous vertebroplasty (EPV)
Arm Type
Experimental
Arm Description
Surgical procedure of percutaneous vertebroplasty.
Arm Title
Standard Conservative treatment (CT)
Arm Type
Active Comparator
Arm Description
Thoracolumbar corset.
Intervention Type
Device
Intervention Name(s)
Early percutaneous vertebroplasty (EPV)
Intervention Description
Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.
Intervention Type
Device
Intervention Name(s)
Standard Conservative treatment (CT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
Description
Difference in the kyphotic angle measured at the fracture diagnosis and after 3 months of treatment
Time Frame
Diagnosis, and after 3 months of treatment
Secondary Outcome Measure Information:
Title
Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups
Description
Pain will be assessed using a Visual Analogic Scale (score from 0 to 10)
Time Frame
diagnosis, after 24 hours, 45 days and 3 months of treatment
Title
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle
Description
Kyphotic angle (KA)
Time Frame
Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Title
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height
Description
Anterior vertebral height (HA)
Time Frame
Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Title
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio
Description
Vertebral Compression Ratio (AP)
Time Frame
Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Title
Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle
Description
Regional kyphotic angle (RA)
Time Frame
Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Title
Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling
Description
Evaluation of the quality of cement filling as poor / acceptable / satisfactory, according to the method described in L.Garnier and col, 2012.
Time Frame
Immediately post-op
Title
Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment
Description
Number of thoracolumbar corset readjustments carried out during follow up (3 months)
Time Frame
3 months
Title
Evaluation of the observance of the treatment by corset (CT arm)
Description
Daily observance report of thoracolumbar corset wear during follow up (3 months)
Time Frame
3 months
Title
Comparison of the adverse events during the study between the two groups
Description
Numbers of adverse events (classification : minor, mild, severe)
Time Frame
3 months
Title
Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups
Description
Physical performance will be assessed using Short Physical Performance Battery test (SPPB, score from 0 to 12)
Time Frame
24 hours and 3 months after treatment
Title
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
Description
ADL (Activities of Daily living) questionnaire score
Time Frame
Diagnosis (before / after fracture), and 3 months after treatment
Title
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
Description
IADL (Instrumental ADL) questionnaire score
Time Frame
Diagnosis (before / after fracture), and 3 months after treatment
Title
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
Description
SF-36 (Short Form-36 Health Survey) questionnaire score
Time Frame
Diagnosis (before / after fracture), and 3 months after treatment
Title
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
Description
QUALEFFO (Quality of life questionnaire of the European Foundation for Osteoporosis) questionnaire score
Time Frame
Diagnosis (before / after fracture), and 3 months after treatment
Title
Comparison of the number of days of hospitalization between the two groups
Description
Length of hospitalization (days)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Boudissa, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22939104
Citation
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.
Results Reference
background
Learn more about this trial
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures
We'll reach out to this number within 24 hrs