Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

NCT03617094 | Completed

• 1 other identifier: 38RC17.276
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Fracture

Keywords

Vertebral fracture; Early Percutaneous Vertebroplasty; Standard Conservative Treatment; Kyphosis angle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups

  diagnosis, after 24 hours, 45 days and 3 months of treatment

• Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle

  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

  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

  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

  Diagnosis, immediat post-op, after 45 days and 3 months of treatment

Study Arms (2)

Early percutaneous vertebroplasty (EPV)

EXPERIMENTAL

Surgical procedure of percutaneous vertebroplasty.

Device: Early percutaneous vertebroplasty (EPV)

Standard Conservative treatment (CT)

ACTIVE COMPARATOR

Thoracolumbar corset.

Device: Standard Conservative treatment (CT)

Interventions

Early percutaneous vertebroplasty (EPV) DEVICE

Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.

Early percutaneous vertebroplasty (EPV)

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.

Standard Conservative treatment (CT)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (1)

University Hospital, Grenoble

Grenoble, 38043, France

Location

Related 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.

  PMID: 22939104 BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Mehdi Boudissa, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: August 6, 2018
• Study Start: July 5, 2018
• Primary Completion: October 17, 2020
• Study Completion: October 17, 2020
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

FR (1)