Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

Completed · Phase 4

Conditions studied: Vertebral Compression Fracture

In brief

Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.

Key facts

Study ID

NCT01383616

Run by

Hospital for Special Surgery, New York

People needed

84

Starts

2006-07-01

Expected to finish

2012-12-01

Last updated by the study team

2017-07-02

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.

You may not qualify if…

• primary tumors of bone or evidence of metastasis at the index vertebrae
• pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis
• fracture secondary to a traumatic event
• inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.