Comparative Study of Balloon Kyphoplasty and Conservative Treatment

NCT00749242 | Completed Phase 4

• 1 other identifier: P060110
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two treatments in acute stable traumatic vertebral fractures (types A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings:

1. 1.Conservative Orthopedic Management consisting of brace and pain medication.
2. 2.Percutaneous 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. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure.

Conditions

SPINAL Fracture

Keywords

Traumatic vertebral fracture; Vertebroplasty; Balloon kyphoplasty; Bohler bracing

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the variation of the angle of Vertebral Kyphosis or, in the case of asymmetrical fractures, the angle of lateral vertebral inclination between inclusion and one year follow-up examination

  1 year

Secondary Outcomes (11)

• Pain evaluation using a visual analogic scale

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

• questionnaire for back pain evaluation : Eifel

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

• Quality of life evaluation (SF 12).

  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 (2)

1

OTHER

conventional orthopedic brace with antalgic treatment

Other: orthopedic brace

2

OTHER

balloon kyphoplasty introduction of balloon into the vertebral body, inflation of the balloon which creates a cavity, then balloon is deflated and removed , then introduction of the cement into the cavity.

Device: balloon kyphoplasty

Interventions

orthopedic brace OTHER

antalgic drugs and orthopedic brace

Also known as: böhler brace

1

balloon kyphoplasty DEVICE

introduction of balloon into the vertebral body, inflation of the balloon which creates a cavity, then balloon is deflated and removed , then introduction of the cement into the cavity.

2

Eligibility Criteria

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

You may qualify if:

• Preliminary clinical exam (the anesthetist must have provided his approval for the surgical procedure)
• Patient must have signed the consent form (ZELEN Randomization protocol)
• Male or Female, 18 years or older;
• Thoracic vertebral Kyphosis \>15° or Lumbar vertebral Kyphosis \> 10°, or Lateral angulation \> 10°.
• Pain with VAS ≥ 5.
• The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during balloon kyphoplasty, or by one year follow-up in the Böhler Brace Group.
• Technical feasibility of a balloon kyphoplasty and Bohler bracing within 7 days after patient randomization.

You may not qualify if:

• Vertebral fracture of more than 10 day duration
• Vertebral fracture not located between T11 and L5
• Vertebral fracture type different from types A1, A2 and A3.1 according to MAGERL classification.
• Thoracic vertebral Kyphosis ≤ 15° or Lumbar vertebral Kyphosis ≤ 10°, or Lateral angulation ≤ 10°.
• Osteoporotic vertebral fracture
• Association to other post traumatic fractures.
• Neurological signs or symptoms related to the vertebral fracture
• History of spine fracture, kyphoplasty, spine surgery at thoracic or lumbar levels with low back pain.
• History of surgery is not per sue a contraindication if there is no residual low back pain. However, in case of spinal fusion history, the fracture to be treated should be at minimum of two disc space from the most proximal or distal end of the fusion.
• Current infection
• Impossibility to perform the percutaneous approach of the vertebra to treat.
• Known allergy to the contrast product used during the Kyphoplasty procedure or to any of the cement components
• 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

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

Spinal Fractures

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Vertebroplasty; 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: 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: 2012-11

Locations

FR (1)