Comparative Study of Balloon Kyphoplasty and Conservative Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00749242
• Date of registration: 08/09/2008
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Comparative Study of Balloon Kyphoplasty and Conservative Treatment TRAUMAA1-2-3
• Scientific title: Prospective Randomized Study Comparing Balloon Kyphoplasty and Conservative Treatment in Acute Traumatic Vertebral Fractures, Types A1, A2, AND A3.1 According to the Magerl Classification (STIC 3)
• Date of first enrolment: December 2007
• Target sample size: 41
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00749242
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Jean-Denis LAREDO, MD, Pr
• Affiliation: AP-HP Assistance Publique- Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Preliminary clinical exam (the anesthetist must have provided his approval for the
surgical procedure)

- Patient must have signed the consent form (ZELEN Randomization protocol)

- Male or Female, 18 years or older;

- One to three traumatic fractures, non pathological, painful, less than 10 days of
age, between T11 and L5 MAGERL A1 or A2 or A3.1. all the fractures should meet the
inclusion criteria(deformity, aetiology, technical possibility of doing procedure).
All fractures should received the same treatment

- Thoracic vertebral Kyphosis >15° or Lumbar vertebral Kyphosis > 10°, or Lateral
angulation > 10°.

- Pain with VAS = 5.

- The benign nature of the vertebral fracture has to be confirmed by the results of the
biopsy performed during balloon kyphoplasty, or by one year follow-up in the Böhler
Brace Group.

- Technical feasibility of a balloon kyphoplasty and Bohler bracing within 7 days after
patient randomization.

Exclusion Criteria:

- Vertebral fracture of more than 10 day duration

- Vertebral fracture not located between T11 and L5

- Vertebral fracture type different from types A1, A2 and A3.1 according to MAGERL
classification.

- Thoracic vertebral Kyphosis = 15° or Lumbar vertebral Kyphosis = 10°, or Lateral
angulation = 10°.

- Osteoporotic vertebral fracture

- Association to other post traumatic fractures.

- Neurological signs or symptoms related to the vertebral fracture

- History of spine fracture, kyphoplasty, spine surgery at thoracic or lumbar levels
with low back pain.

History of surgery is not per sue a contraindication if there is no residual low back
pain. However, in case of spinal fusion history, the fracture to be treated should be at
minimum of two disc space from the most proximal or distal end of the fusion.

- Current infection

- Impossibility to perform the percutaneous approach of the vertebra to treat.

- Known allergy to the contrast product used during the Kyphoplasty procedure or to any
of the cement components

- 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

- Malignant and traumatic vertebral fractures

- Contraindication to MRI :

Metallic implant : pacemaker, non-movable auditive implant, metallic vascular or cardiac
device Metallic surgical clips Claustrophobia

- Evolutive cardiac disease nonreactive to medical treatment

- Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

SPINAL Fracture

Intervention(s)

Device: balloon kyphoplasty

Other: orthopedic brace

Primary Outcome(s)

The primary outcome is the variation of the angle of Vertebral Kyphosis or, in the case of asymmetrical fractures, the angle of lateral vertebral inclination between inclusion and one year follow-up examination [Time Frame: 1 year]

Secondary Outcome(s)

questionnaire for back pain evaluation : Eifel [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Quality of life evaluation (SF 12). [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts tomodensitometry (TDM) on the sagittal level : lateral right, median and lateral left [Time Frame: preoperative, at J6 and at J360]

Changes in height of the intervertebral disc spaces adjacent to the treated vertebra [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Intensity of signal with T2 sequence [Time Frame: preoperative and at J360]

Number of new vertebral fractures occurring during the one year follow-up period. [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Changes in anterior, mid and posterior vertebral heights of the treated vertebral body [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Cost evaluation in a sample of 10% of patients randomly selected including the following costs : o Intervention cost.o Medical treatment costs o Consultation costs. o Hospitalization cost o Complication costs [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Analgesics intake according to the WHO classification (Classes 1, 2 and 3). [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Pain evaluation using a visual analogic scale [Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360]

Secondary ID(s)

P060110

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, France