Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00749060
• Date of registration: 08/09/2008
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures OSTEO-6
• Scientific title: Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks
• Date of first enrolment: December 2007
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00749060
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Laredo Jean-Denis, MD,Pr

• Name: Jean-Denis LAREDO, M.D.Pr.

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure

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

- Male or female, 50 years or older

- One or two non-traumatic vertebral fracture(s):

- Of osteoporotic origin (low speed trauma such as fall from his own height or
less than 80 cm)

- Fracture(s) of less than 6 weeks duration after the onset of pain related to the
fracture The fracture(s) exhibit(s) high signal intensity on T2-weighted images
and a benign appearance at MRI

- The patient will be able to receive the selected protocol treatment within 6 weeks
after onset of fracture-related symptoms and within 15 days after treatment
randomization.

- The benign nature of the vertebral fracture has to be confirmed by the results of the
biopsy performed during vertebroplasty or balloon kyphoplasty or by one year
follow-up in the conservative treatment group.

Exclusion Criteria:

- Patient with a vertebral fracture of more than 6 week duration after onset of
fracture-related symptoms.

- Neurological signs related to the vertebral fracture to treat

- History of surgical or percutaneous spine treatment except simple discectomy at a
single or multiple vertebral levels with no residual pain.

- 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.

- Known allergy to a contrast media or to one of the cement components used for
kyphoplasty.

- Vertebral fracture with loss of 90%or more of the vertebral body height

- Neurological signs or symptoms related to the vertebral fracture

- Malignant and traumatic vertebral fractures

- Contraindication to MRI :

- Metallic implant : pace-maker, non AMOVIBLE 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.

- Presence of an unexplained biological inflammatory syndrome with NFS=20

- 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: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Between T5 and L5

of Less Than 6 Weeks Duration

Osteoporotic Vertebral Fracture

Intervention(s)

Other: conventional treatment

Procedure: kyphoplasty with balloons

Procedure: vertebroplasty

Primary Outcome(s)

Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements. [Time Frame: 1 year]

Secondary Outcome(s)

1° - Pain evaluation using a visual analogic scale [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]

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]

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]

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]

EIFEL questionnaire for back pain evaluation [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 TDM on the sagittal level : lateral right, median and lateral left [Time Frame: preoperative, at J6 and at 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]

Quality of life evaluation (QUALEFFO - SF 12). [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]

Secondary ID(s)

P060107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, France