Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Ministry of Health, France
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00749060

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

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks

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

Primary Outcome Measures:

Change in Regional 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 - SF 12). [ 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 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 ]

Estimated Enrollment:	300
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 conventional treatment	Other: conventional treatment with our without brace
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

Contacts

Contact: LAREDO Jean-Denis, M.D.Pr.

+331 49 95 9106

jean-denis.laredo@lrb.aphp.fr

Locations

France
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire	Recruiting
Paris, France, 75010
Contact: Laredo Jean-Denis, MD,Pr +331 4995 9106 jean-denis.laredo@lrb.aphp.fr/jean-denis.laredo@uphs.upenn.edu
Sub-Investigator: Hamze Bassam, MD
Principal Investigator: Laredo Jean-Denis, M.D.,PR.
Sub-Investigator: Bossard Philippe, MD
Sub-Investigator: Vergnol Jean-François, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Ministry of Health, France

Investigators

Principal Investigator:

LAREDO Jean-Denis, MD,Pr

AP-HP Assistance Publique- Hôpitaux de Paris

More Information

Responsible Party:	Department of clinical research and development ( Cécile JOURDAIN )
Study ID Numbers:	P060107, 2006-A00467-44
Study First Received:	September 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00749060
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

osteoporosis
non-traumatic vertebral fracture
vertebral compression
Balloon kyphoplasty
vertebroplasty

Study placed in the following topic categories:

Polymethyl Methacrylate
Spinal Injuries
Fractures, Bone
Back Injuries

Wounds and Injuries
Spinal Fractures
Disorders of Environmental Origin
Osteoporosis

ClinicalTrials.gov processed this record on January 14, 2009