Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation

NCT00749229 | Terminated Phase 4

• 1 other identifier: P060109
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance. Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.

Conditions

One or Two Traumatic Vertebral Fractures; Located Between T11 and L5; Balloon Kyphoplasty

Keywords

Traumatic vertebral fracture; Balloon Kyphoplasty; type A3.2, or A3.3 or B1 or C1 in the MAGERL CLASSIFICATION

Outcome Measures

Primary Outcomes (1)

• Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements

  1 year

Secondary Outcomes (10)

• Pain evaluation using a visual analogic scale

  J-20 to J-7 - J6 - J45 - J90 - J180 - J360

• EIFEL questionnaire for back pain evaluation

  J-20 to J-7 - J6 - J45 - J90 - J180 - J360

• Quality of life evaluation (SF 12).

  J-20 to J-7 - J6 - J45 - J90 - J180 - J360

• Analgesics intake according to the WHO classification (Classes 1, 2 and 3).

  J-20 to J-7 - J6 - J45 - J90 - J180 - J360

• Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle.

  J-20 to J-7 - J6 - J45 - J90 - J180 - J360

Study Arms (1)

1

OTHER

Balloon kyphoplasty

Device: balloon kyphoplasty

Interventions

balloon kyphoplasty DEVICE

During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength

1

Eligibility Criteria

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

You may qualify if:

• Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure)
• Patient must have signed the consent form
• Male or female patient aged 18 or over
• One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle \> 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression
• Fracture with or without neurological difficulties
• Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure.

You may not qualify if:

• Non- traumatic, malignant or osteoporotic vertebral fractures
• History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
• Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
• More than two recent vertebral fractures
• Current infection
• Impossibility to perform the percutaneous approach of the vertebra to treat.
• Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat.
• Vertebral fracture with loss of 90%or more of the vertebral body height
• Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
• Evolutive cardiac disease nonreactive to medical treatment
• Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.
• Pregnant or breast feeding women
• Patient not affiliated to social security

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Service de Radiologie, Hôpital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Interventions

Kyphoplasty

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jean-Denis LAREDO, M.D.,PR.

  AP/HP Assistance Publique-Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 4, 2017

Record last verified: 2014-12

Locations

FR (1)