Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures (AGIL11)

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Fracture
• Intervention / Treatment: Device: Early percutaneous vertebroplasty (EPV); Device: Standard Conservative treatment (CT)

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • University Hospital, Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early percutaneous vertebroplasty (EPV); Surgical procedure of percutaneous vertebroplasty.	Device: Early percutaneous vertebroplasty (EPV); Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.
Active Comparator: Standard Conservative treatment (CT); Thoracolumbar corset.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Comparison of the adverse events during the study between the two groups	Numbers of adverse events (classification : minor, mild, severe)	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)	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	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	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	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	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)	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Clinical Investigation Centre for Innovative Technology Network
• Investigators: Principal Investigator: Mehdi Boudissa, MD, University Hospital, Grenoble

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Actual): October 17, 2020
• Study Completion (Actual): October 17, 2020

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Vertebral fracture; Early Percutaneous Vertebroplasty; Standard Conservative Treatment; Kyphosis angle
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: 38RC17.276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No