Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

Overview

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.

Full Title of Study: “Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Early percutaneous vertebroplasty (EPV)
    • Surgical procedure of percutaneous vertebroplasty.
  • Active Comparator: Standard Conservative treatment (CT)
    • Thoracolumbar corset.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
    • 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
    • Time Frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
    • Kyphotic angle (KA)
  • 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
    • Anterior vertebral height (HA)
  • 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
    • Vertebral Compression Ratio (AP)
  • 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
    • Regional kyphotic angle (RA)
  • Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling
    • Time Frame: Immediately post-op
    • 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
    • Time Frame: 3 months
    • Number of thoracolumbar corset readjustments carried out during follow up (3 months)
  • Evaluation of the observance of the treatment by corset (CT arm)
    • Time Frame: 3 months
    • Daily observance report of thoracolumbar corset wear during follow up (3 months)
  • Comparison of the adverse events during the study between the two groups
    • Time Frame: 3 months
    • Numbers of adverse events (classification : minor, mild, severe)
  • 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
    • 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
    • Time Frame: Diagnosis (before / after fracture), and 3 months after treatment
    • 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
    • Time Frame: Diagnosis (before / after fracture), and 3 months after treatment
    • 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
    • Time Frame: Diagnosis (before / after fracture), and 3 months after treatment
    • 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
    • Time Frame: Diagnosis (before / after fracture), and 3 months after treatment
    • 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
    • Time Frame: 3 months
    • Length of hospitalization (days)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Collaborator
    • Clinical Investigation Centre for Innovative Technology Network
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mehdi Boudissa, MD, Principal Investigator, University Hospital, Grenoble

References

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.

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