Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

NCT ID: NCT03617094

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2020-10-17

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.

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.

Conditions

Vertebral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Early percutaneous vertebroplasty (EPV)

Surgical procedure of percutaneous vertebroplasty.

Group Type: EXPERIMENTAL

Early percutaneous vertebroplasty (EPV)

Intervention Type: DEVICE

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

Standard Conservative treatment (CT)

Thoracolumbar corset.

Group Type: ACTIVE_COMPARATOR

Standard Conservative treatment (CT)

Intervention Type: 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.

Interventions

Early percutaneous vertebroplasty (EPV)

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehdi Boudissa, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital, Grenoble

Grenoble, , France

Countries

France

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.

Reference Type: BACKGROUND

PMID: 22939104 (View on PubMed)

Other Identifiers

38RC17.276

Identifier Type: -

Identifier Source: org_study_id