Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute 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:
NCT00749086
First received: September 8, 2008
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following:

  1. 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.
  2. 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 to fix fracture reduction. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than vertebroplasty.

Condition Intervention Phase
Osteoporotic Vertebral Fracture
Between T5 and L5
Chronic Arthritis, Longer Than Six Weeks Duration
Device: balloon kyphoplasty
Procedure: vertebroplasty
Phase 4

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 Study of Balloon Kyphoplasty and Vertebroplasty in Subacute (Older Than 6 Weeks) Osteoporotic Vertebral Fractures (STIC2)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Modification of the kyphotic angle of every treated vertebra (between the preoperative angle and measured after 1 year follow-up) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of pain through the visual analog scale [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Functional scale (EIFEL) for lumbar pain [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Evaluation of quality of life (QUALEFFO - SF 12) [ Time Frame: J-20 to 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 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Evaluation of kyphotic angle and global thoracic and lumbar angulations [ Time Frame: At each follow-up visit (J-20 to J-7 - J6 - J45 - J90 - J180 - J360) : ] [ Designated as safety issue: Yes ]
  • Measurement of anterior, median and posterior height of the discs adjacent to the fracture; [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Measurement of disc angles adjacent to the fracture; [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Number of new vertebral fractures documented radiologically [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Medico-economic follow-up on 10% of the randomly selected patients:o Cost of intervention.o Cost of prescribed medicines.o Cost of follow-up visits.o Cost of subsequent hospitalization.o Cost of complications. [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: No ]
  • Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts CT-SCAN 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: 97
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
Experimental: 2
balloon kyphoplasty
Device: balloon kyphoplasty
Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is first placed into the fractured vertebra and inflated with fluid in order to create a cavity. Then, the balloon are deflated and removed. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure.
Active Comparator: 1
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

  Show Detailed Description

  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 has read and sign the informed consent
  • 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) older 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
  • Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
  • The patient will be able to receive the selected protocol treatment 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.

Exclusion Criteria:

  • Patient with a vertebral fracture of less 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.
  • Patient with more than 2 fractures corresponding to the inclusion criteria (old fractures are not taken into account)
  • 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.
  • Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
  • 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 : pace-maker, no auditive implant , metallic vascular or AMOVIBLE 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 VS≥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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749086

Locations
France
Service de Radiologie, Hôpital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Jean-Denis LAREDO, M.D.,PR. AP-HP Assistance Publique- Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00749086     History of Changes
Other Study ID Numbers: P060108
Study First Received: September 8, 2008
Last Updated: November 9, 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:
Arthritis
Fractures, Bone
Spinal Fractures
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on August 27, 2014