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Completed

NCT Number: NCT03617094

Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

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.

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Key information

Conditions

Vertebral Fracture Back Injuries Fractures, Bone Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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.

  7. 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)

  8. 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)

  9. Comparison of the adverse events during the study between the two groups

    Time frame: 3 months

    Numbers of adverse events (classification : minor, mild, severe)

  10. 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)

  11. 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

  12. 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

  13. 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

  14. 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

  15. Comparison of the number of days of hospitalization between the two groups

    Time frame: 3 months

    Length of hospitalization (days)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

Registry information

Official study title

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

Acronym: AGIL11

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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