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Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures (OSTEO-6)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00749060
First received: September 8, 2008
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.


Condition Intervention
Osteoporotic Vertebral Fracture
Between T5 and L5
of Less Than 6 Weeks Duration
 Other: conventional treatment
Procedure: kyphoplasty with balloons
Procedure: vertebroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1° - Pain evaluation using a visual analogic scale [ Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360 ] [ Designated as safety issue: Yes ]
  • eifel questionnaire for back pain evaluation [ Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360 ] [ Designated as safety issue: Yes ]
  • Quality of life evaluation (QUALEFFO - Short-Form SF12). [ Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360 ] [ Designated as safety issue: Yes ]
  • Analgesics intake according to the WHO classification (Classes 1, 2 and 3). [ Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360 ] [ Designated as safety issue: Yes ]
  • Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle [ Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Intensity of signal with T2 sequence [ Time Frame: preoperative and at J360 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: December 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
conventional treatment
 Other: conventional treatment
with our without brace
Other Name: antalgic drugs
2
kyphoplasty by balloons
 Procedure: kyphoplasty with balloons
Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity.
3
vertebroplasty
 Procedure: vertebroplasty
Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance

Detailed Description:

The three treatments are the following: 1/Conventional medical treatment including rest and pain medications2/Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.3/Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement may be injected with low pressure into the created cavity. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than medical treatment and vertebroplasty.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749060

Locations
France
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Jean-Denis LAREDO, MD,Pr AP-HP Assistance Publique- Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00749060     History of Changes
Other Study ID Numbers: P060107
Study First Received: September 8, 2008
Last Updated: November 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
osteoporosis
non-traumatic vertebral fracture
vertebral compression
Balloon kyphoplasty
vertebroplasty

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on May 16, 2013