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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Lane, MD, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01383616
First received: June 13, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes

June 13, 2011
April 3, 2013
July 2006
December 2012   (final data collection date for primary outcome measure)
Clinical improvement by patient reported questionnaires [ Time Frame: Preoperative questionnaires within 3 weeks before surgery and postoperative questionnaires at 3 months and 12 months after surgery ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01383616 on ClinicalTrials.gov Archive Site
  • Vertebral body height restoration following surgery with kyphoplasty [ Time Frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1 ] [ Designated as safety issue: No ]
    Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior and middle vertebral body heights
  • Measurement of change in Kyphotic (Cobb) angle following kyphoplasty [ Time Frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1 ] [ Designated as safety issue: No ]
    Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery
Same as current
Not Provided
Not Provided
 
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vertebral Compression Fracture
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.
  • Active Comparator: 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.
    Intervention: Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
  • Active Comparator: 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.
    Intervention: Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01383616
26033
Yes
Joseph Lane, MD, Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Study Director: Tzipora Kuba, PhD Hospital for Special Surgery, New York
Principal Investigator: Joseph M Lane, MD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP