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

NCT00749060 | Completed

• 1 other identifier: P060107
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (11)

• 1° - Pain evaluation using a visual analogic scale

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

• questionnaire (Eifel) for back pain evaluation

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

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

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

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

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

• Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle

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

Study Arms (3)

1

OTHER

conventional treatment

Other: conventional treatment

2

OTHER

kyphoplasty by balloons

Procedure: kyphoplasty with balloons

3

OTHER

vertebroplasty

Procedure: vertebroplasty

Interventions

conventional treatment OTHER

with our without brace

Also known as: antalgic drugs

1

kyphoplasty with balloons PROCEDURE

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.

2

vertebroplasty PROCEDURE

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire

Paris, 75010, France

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Kyphoplasty; Vertebroplasty

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jean-Denis LAREDO, MD,Pr

  AP-HP Assistance Publique- Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

FR (1)