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Osteoporotic Vertebral FracturePhase 4OSTEO+6NCT00749086

Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures

A Phase 4 study testing balloon kyphoplasty 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 two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following: 1. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
balloon kyphoplasty and vertebroplasty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteFrance
Study dates
Dec 2007to Jun 2012
Phase
Phase 4
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 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
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  • 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.

Who cannot join

  • 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
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  • 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 movable 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Service de Radiologie, Hôpital Lariboisière

    Paris, 75010

Other trials in France

About this study

Official title: Prospective Randomized Study of Balloon Kyphoplasty and Vertebroplasty in Subacute (Older Than 6 Weeks) Osteoporotic Vertebral Fractures (STIC2)

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.
Read the detailed description

Vertebral compression fractures can occur at any level in the vertebral column but the most frequent ones occur at the thoracic (T8-T12) and lumbar spine (L1 and L4). Multiple vertebrae are often concerned. Vertebral fractures are characterized by height reduction of the involved vertebral bodies and very often also by kyphosis and laterally dorsal pain laterally irradiating towards the two sides of the back. A spontaneous improvement of this pain can occur spontaneously within 6 to 12 weeks, but a large number of patients develop a chronic pain and associated morbidity, due to the side effects caused by the fractureThe main cause (85%) of non-traumatic vertebral compression fractures is osteoporosis, in particular in elderly patients. In osteoporotic vertebral fractures older than 6 weeks, conservative management is purely symptomatic, with no effect on the compression fracture itself. Two alternatives are available: Percutaneous Vertebroplasty and Percutaneous Balloon Kyphoplasty

  1. Percutaneous Vertebroplasty is a percutaneous treatment of vertebral fractures which is used now for more than 25 years. It was first reported in aggressive vertebral hemangiomas and vertebral malignancies and than in osteoporotic vertebral fractures. More recently, vertebroplasty was used in traumatic vertebral fracture.Vertebroplasty is performed under fluoroscopic guidance with the patient in prone position under general or local anesthesia and conscious sedation. A trocar needle is inserted through a posterior approach into the vertebral neural arch and pedicle, up to the fractured vertebral body. Depending on cases a unilateral or bilateral approach is used. A bilateral approach is used in the cases of traumatic fractures. Once the needle is well positioned into the vertebral body as checked on apical and Lateral views, a radio-opaque cement, in a viscous phase, is slowly injected into the vertebral body under continuous fluoroscopic control. The injection is stopped in case of cement leakage outside from the vertebral body. Polymethylmetacrylate is the most commonly used cement. Its biologic compatibility is well established since used in orthopedic surgery for many decades. Some operators are reluctant to use a non-resorbable cement in young patients. However, to date, the ideal resorbable injectable cement to be discovered. Vertebroplasty allows rapid fracture fixation and decrease in pain, thus allowing the patient to resume walking and daily activities in the days following the procedure. Vertebroplasty does not reduce significantly the kyphosis angle due to the fracture unless nonunion is present in the fracture line.
  2. Percutaneous Balloon Kyphoplasty is a variant of vertebroplasty which is performed under general anaesthesia using the KyphX® System (Medtronic, Sunnyvale, California). Balloon kyphoplasty aims at restore vertebral height of the fractured vertebra using an inflatable balloon prior to inject surgical cement (PMMA) into the vertebral body and fix the fracture. It is an expensive technique costing around 4,000 euros for up to 2 vertebrae in the same patient. The surgical technique for the procedure has been described by Lieberman et al. A bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body. Fluoroscopy is used to insert the tools and control the procedure. With reaming tools, two working channels are created and the balloons are inserted. The balloons are available in lengths of 10, 15 and 20 mm.The two balloons(one on each side) should ideally be centered at middle height between the superior and inferior endplates and in the anterior two-thirds of the vertebral body. Balloon placement into the vertebral body is checked using radiopaque markers at the two extremities of the balloon. Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity. Inflation is stopped when one of the following inflation endpoints is reached: pressure raised over 400 psi, balloon contacts one of the cortical bone of the vertebra or reaching maximal balloon inflation volume. The balloons are then deflated and removed. The mean balloon inflation volume is 2 to 3ml. The Bone Filler Device, filled before with 1.5 ml of polymethylmethacrylate (PMMA), is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula. This step is repeated till a complete fill of the cavity is obtained. The same procedure is repeated through the other working cannula at the contra-lateral pedicle. Filling of the cavity with highly viscous PMMA is performed under continuous fluoroscopic control.
Being tested
balloon kyphoplasty, 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.

  • balloon kyphoplastyDevice

    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.

  • 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 NCT00749086
Study groupRoleWhat they receive
2Experimentalballoon kyphoplasty
Receives: Device: balloon kyphoplasty
1Active comparatorvertebroplasty
Receives: Procedure: vertebroplasty

What is being measured

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

  1. Modification of the kyphotic angle of every treated vertebra (between the preoperative angle and measured after 1 year follow-up)

    Measured: 1 year

Secondary outcomes (11)
  1. Evaluation of pain through the visual analog scale

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

  2. Functional scale (EIFEL) for lumbar pain

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

  3. Evaluation of quality of life (QUALEFFO - Short Form SF12)

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

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

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

  5. Evaluation of kyphotic angle and global thoracic and lumbar angulations

    Measured: At each follow-up visit (J-20 to J-7 - J6 - J45 - J90 - J180 - J360) :

  6. Measurement of anterior, median and posterior height of the discs adjacent to the fracture;

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

  7. Measurement of disc angles adjacent to the fracture;

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

  8. Number of new vertebral fractures documented radiologically

    Measured: J-20 to J-7 - J6 - J45 - J90 - J180 - J360

  9. 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.

    Measured: J-20 to 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 CT-SCAN 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749086
Sponsor's protocol ID
P060108
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 Phase 4 study testing balloon kyphoplasty 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 9 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Modification of the kyphotic angle of every treated vertebra (between the preoperative angle and measured after 1 year follow-up) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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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