Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

University of Virginia

Status and phase: Completed; Phase 3

Conditions: Osteoporotic Vertebral Compression Fractures

Treatments: Procedure: Kyphoplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00279877

12031

Details and patient eligibility

About

Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Enrollment: 112 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• > or = 50 years of age
• Compression fracture (T4-L5)within previous 12 mo.
• Pain from compression fracture
• No malignant tumor
• No back surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

vertebroplasty

Active Comparator group

Description:

vertebroplasty

Treatment:

Procedure: Kyphoplasty

kyphoplasty

Active Comparator group

Description:

kyphoplasty

Treatment:

Procedure: Kyphoplasty