Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures

NCT00749086 | Completed Phase 4

• 1 other identifier: P060108
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Osteoporotic Vertebral Fracture; Between T5 and L5; Chronic Arthritis, Longer Than Six Weeks Duration

Keywords

Osteoporosis; Non-traumatic vertebral fracture; Vertebral compression; Balloon kyphoplasty; Vertebroplasty

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (11)

• Evaluation of pain through the visual analog scale

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

• Functional scale (EIFEL) for lumbar pain

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

• Evaluation of quality of life (QUALEFFO - Short Form SF12)

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

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

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

• Evaluation of kyphotic angle and global thoracic and lumbar angulations

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

Study Arms (2)

2

EXPERIMENTAL

balloon kyphoplasty

Device: balloon kyphoplasty

1

ACTIVE COMPARATOR

vertebroplasty

Procedure: vertebroplasty

Interventions

balloon kyphoplasty DEVICE

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.

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

1

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 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
• 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.

You may not qualify if:

• 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.
• Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
• More than two recent vertebral fractures
• 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

Sponsors & Collaborators

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

Study Sites (1)

Service de Radiologie, Hôpital Lariboisière

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, M.D.,PR.

  AP-HP Assistance Publique- Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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)