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

Primary Purpose

Osteoporotic Vertebral Fracture, Between T5 and L5, of Less Than 6 Weeks Duration

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

conventional treatment

kyphoplasty with balloons

vertebroplasty

About this trial

This is an interventional treatment trial for Osteoporotic Vertebral Fracture focused on measuring osteoporosis, non-traumatic vertebral fracture, vertebral compression, Balloon kyphoplasty, vertebroplasty

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Arm Description

conventional treatment

kyphoplasty by balloons

vertebroplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1° - Pain evaluation using a visual analogic scale

questionnaire (Eifel) for back pain evaluation

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

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

Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle

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

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

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

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

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

Intensity of signal with T2 sequence

Full Information

NCT ID

NCT00749060

First Posted

September 8, 2008

Last Updated

December 13, 2014

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT00749060

Brief Title

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

Acronym

OSTEO-6

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporotic Vertebral Fracture, Between T5 and L5, of Less Than 6 Weeks Duration

Keywords

osteoporosis, non-traumatic vertebral fracture, vertebral compression, Balloon kyphoplasty, vertebroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

conventional treatment

Arm Title

Arm Type

Other

Arm Description

kyphoplasty by balloons

Arm Title

Arm Type

Other

Arm Description

vertebroplasty

Intervention Type

Other

Intervention Name(s)

conventional treatment

Other Intervention Name(s)

antalgic drugs

Intervention Description

with our without brace

Intervention Type

Procedure

Intervention Name(s)

kyphoplasty with balloons

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

vertebroplasty

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

1° - Pain evaluation using a visual analogic scale

Time Frame