Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

Vertebral Fracture Clinical Trial

— AGIL11  

Official title:

Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617094
• Other study ID #: 38RC17.276
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: October 17, 2020

Study information

• Verified date: January 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This is a monocentric, randomized, parallel group, prospective and open-label study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 17, 2020
• Est. primary completion date: October 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Vertebral Fracture

Intervention

Device:
• Early percutaneous vertebroplasty (EPV)
Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.
• 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.

Locations

Country	Name	City	State
France	University Hospital, Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnosis, and after 3 months of treatment
Secondary	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)	diagnosis, after 24 hours, 45 days and 3 months of treatment
Secondary	Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle	Kyphotic angle (KA)	Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Secondary	Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height	Anterior vertebral height (HA)	Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Secondary	Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio	Vertebral Compression Ratio (AP)	Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Secondary	Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle	Regional kyphotic angle (RA)	Diagnosis, immediat post-op, after 45 days and 3 months of treatment
Secondary	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.	Immediately post-op
Secondary	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)	3 months
Secondary	Evaluation of the observance of the treatment by corset (CT arm)	Daily observance report of thoracolumbar corset wear during follow up (3 months)	3 months
Secondary	Comparison of the adverse events during the study between the two groups	Numbers of adverse events (classification : minor, mild, severe)	3 months
Secondary	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)	24 hours and 3 months after treatment
Secondary	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	Diagnosis (before / after fracture), and 3 months after treatment
Secondary	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	Diagnosis (before / after fracture), and 3 months after treatment
Secondary	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	Diagnosis (before / after fracture), and 3 months after treatment
Secondary	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	Diagnosis (before / after fracture), and 3 months after treatment
Secondary	Comparison of the number of days of hospitalization between the two groups	Length of hospitalization (days)	3 months