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

NCT ID: NCT01383616

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

Conditions

Vertebral Compression Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Unipedicular kyphoplasty

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Bipedicular Kyphoplasty group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Interventions

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

A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tzipora Kuba, PhD

Role: STUDY_DIRECTOR

Hospital for Special Surgery, New York

Joseph M Lane, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

26033

Identifier Type: -

Identifier Source: org_study_id