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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
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.
Hospital for Special Surgery
New York, New York, United States
Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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.
Time frame: Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery
Change in RDQ in the Bipedicular Group From 3 to 12 Months
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.
Time frame: 3-12 months post operation
Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.
Time frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
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
Time frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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.
Time frame: 3 months post-op
Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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
Time frame: 3 months post-op
Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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
Time frame: 12 months post-op
Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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.
Time frame: 12 months post-op
Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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
Time frame: 12 months post-op
Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.
Time frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.