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

Vertebral Compression Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383616
• Other study ID #: 26033
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2011
• Last updated: April 3, 2013
• Start date: July 2006
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Spinal Fractures
• Vertebral Compression Fracture

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement by patient reported questionnaires	Clinical improvement recorded using Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RDQ), and Short-Form 36 (SF-36) questionnaires including both Mental (MCS) and Physical (PCS) component subscores of SF-36.	Preoperative questionnaires within 3 weeks before surgery and postoperative questionnaires at 3 months and 12 months after surgery	Yes
Secondary	Vertebral body height restoration following surgery with kyphoplasty	Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior and middle vertebral body heights	Preoperative assessment within 3 weeks before surgery and postoperative day 1	No
Secondary	Measurement of change in Kyphotic (Cobb) angle following kyphoplasty	Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery	Preoperative assessment within 3 weeks before surgery and postoperative day 1	No