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Completed

NCT Number: NCT01383616

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.

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Key information

Conditions

Vertebral Compression Fracture Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2011
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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