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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01383616
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Vertebral Compression Fracture Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Study Start Date : July 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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: 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.
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.




Primary Outcome Measures :
  1. Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery ]
    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

  2. Change in RDQ in the Bipedicular Group From 3 to 12 Months [ Time Frame: 3-12 months post operation ]
    The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.


Secondary Outcome Measures :
  1. Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty [ Time Frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1 ]
    Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.

  2. Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty [ Time Frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1 ]
    Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery

  3. Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 3 months post-op ]
    The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.

  4. Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 3 months post-op ]
    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain

  5. Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 12 months post-op ]
    Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.[2] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible

  6. Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 12 months post-op ]
    The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.

  7. Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 12 months post-op ]
    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain

  8. Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty [ Time Frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1 ]
    Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383616


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Study Director: Tzipora Kuba, PhD Hospital for Special Surgery, New York
Principal Investigator: Joseph M Lane, MD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01383616    
Other Study ID Numbers: 26033
First Posted: June 28, 2011    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Keywords provided by Hospital for Special Surgery, New York:
osteoporosis
vertebral compression fractures
Additional relevant MeSH terms:
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Fractures, Bone
Spinal Fractures
Fractures, Compression
Wounds and Injuries
Spinal Injuries
Back Injuries