- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383616
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
June 3, 2017 updated by: Hospital for Special Surgery, New York
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery
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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.
|
3-12 months post operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Preoperative assessment within 3 weeks before surgery and postoperative day 1
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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
|
Preoperative assessment within 3 weeks before surgery and postoperative day 1
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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.
|
3 months post-op
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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
|
3 months post-op
|
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
|
12 months post-op
|
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.
|
12 months post-op
|
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
|
12 months post-op
|
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.
|
Preoperative assessment within 3 weeks before surgery and postoperative day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Tzipora Kuba, PhD, Hospital for Special Surgery, New York
- Principal Investigator: Joseph M Lane, MD, Hospital for Special Surgery, New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 13, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 28, 2011
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 3, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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