Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Kyphoplasty · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| vertebroplasty | ACTIVE_COMPARATOR | vertebroplasty |
| kyphoplasty | ACTIVE_COMPARATOR | kyphoplasty |
| Name | Type | Description |
|---|---|---|
| Kyphoplasty | PROCEDURE | kyphoplasty |
* \> or = 50 years of age * Compression fracture (T4-L5)within previous 12 mo. * Pain from compression fracture * No malignant tumor * No back surgery
Kyphoplasty is used for osteoporotic vertebral compression fractures, a condition in which weakened vertebrae collapse due to osteoporosis. It is a minimally invasive procedure intended to stabilize the fracture and reduce pain. The treatment is being studied in patients aged 50 years and older.
Kyphoplasty is developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker CAH. The company is conducting clinical research on this procedure for osteoporotic vertebral compression fractures.
Kyphoplasty is in Phase 3 clinical development. It is an investigational procedure and has not been approved by the FDA. A Phase 3 trial has been completed to evaluate its efficacy and cost effectiveness for osteoporotic vertebral compression fractures.
Kyphoplasty has one completed Phase 3 trial, identified as NCT00279877, titled "Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial." This randomized, active-controlled study enrolled 112 participants in the United States and was not double-blinded.
Kyphoplasty is not the same as vertebroplasty. The clinical trial NCT00279877 directly compares kyphoplasty with vertebroplasty as an active control. Both are procedures for vertebral compression fractures, but they are distinct interventions being evaluated for their relative efficacy and cost effectiveness.