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Osteoporotic Vertebral FractureOSTEO-6NCT00749060

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

A study testing conventional treatment, kyphoplasty with balloons and vertebroplasty in people with Osteoporotic Vertebral Fracture and Between T5 and L5, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older
What is being tested?
conventional treatment, kyphoplasty with balloons and vertebroplasty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteFrance
Study dates
Dec 2007to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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 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.
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire

    Paris, 75010

Other trials in France

About this study

Official title: Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks

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

Read the 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.

Being tested
conventional treatment, kyphoplasty with balloons, vertebroplasty
Keywords
osteoporosis, non-traumatic vertebral fracture, vertebral compression, Balloon kyphoplasty, vertebroplasty
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional treatmentOther

    Also called antalgic drugs

    with our without brace

  • kyphoplasty with balloonsProcedure or surgery

    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.

  • vertebroplastyProcedure or surgery

    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

Study groups in NCT00749060
Study groupRoleWhat they receive
1Otherconventional treatment
Receives: Other: conventional treatment
2Otherkyphoplasty by balloons
Receives: Procedure: kyphoplasty with balloons
3Othervertebroplasty
Receives: Procedure: vertebroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements.

    Measured: 1 year

Secondary outcomes (11)

  1. 1° - Pain evaluation using a visual analogic scale

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  2. questionnaire (Eifel) for back pain evaluation

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  3. Quality of life evaluation (QUALEFFO - Short-Form SF12).

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

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

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

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

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  6. Changes in anterior, mid and posterior vertebral heights of the treated vertebral body

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  7. Changes in height of the intervertebral disc spaces adjacent to the treated vertebra

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  8. Number of new vertebral fractures occurring during the one year follow-up period

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  9. 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

    Measured: J-20 à J-7 / J6 / J45 /J90 /J180 / J360

  10. 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

    Measured: preoperative, at J6 and at J360

  11. Intensity of signal with T2 sequence

    Measured: preoperative and at J360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749060
Sponsor's protocol ID
P060107
Acronym
OSTEO-6
Status last verified
Dec 2014
First submitted
8 Sep 2008
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing conventional treatment, kyphoplasty with balloons and vertebroplasty in people with Osteoporotic Vertebral Fracture and Between T5 and L5, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.

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