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

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Vertebral Compression Fracture

Treatments: Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01383616

26033

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Unipedicular kyphoplasty

Active Comparator group

Description:

Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.

Treatment:

Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

Bipedicular Kyphoplasty group

Active Comparator group

Description:

Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.

Treatment:

Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)