Vertebral Compression Fracture
Conditions
Keywords
osteoporosis, vertebral compression fractures
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.
Interventions
DEVICEKyphon® 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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 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. |
| Change in RDQ in the Bipedicular Group From 3 to 12 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 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. |
| Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 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 |
| Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 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 |
| Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty | 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. |
| Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 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 |
| Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty | 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. |
| Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 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. |
| Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unipedicular Kyphoplasty In this arm only vertebral body pedicle was entered to deliver bone cement. 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. | 23 |
| Bipedicular Kyphoplasty Group In this arm two pedicles were entered to deliver bone cement. 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. | 21 |
| Total | 44 |
Baseline characteristics
| Characteristic | Bipedicular Kyphoplasty Group | Unipedicular Kyphoplasty | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 23 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79.3 years STANDARD_DEVIATION 6.5 | 78.7 years STANDARD_DEVIATION 7.8 | 79 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 44 |
| serious Total, serious adverse events | 0 / 40 | 0 / 44 |
Outcome results
Primary
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
Population: From the period of intervention to 12 month follow-up, 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Change in RDQ in the Bipedicular Group From 3 to 12 Months | 4.7 units on a scale | Standard Deviation 1.8 |
p-value: 0.008t-test, 2 sided
Primary
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
Population: From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 15 units on a scale | Standard Deviation 4 |
| Bipedicular Kyphoplasty Group | Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 14 units on a scale | Standard Deviation 5 |
Comparison: Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groupsp-value: 0.85t-test, 2 sided
Secondary
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
Population: Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty | 20.5 percent change | Standard Deviation 15 |
| Bipedicular Kyphoplasty Group | Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty | 14.8 percent change | Standard Deviation 10.9 |
p-value: 0.17t-test, 2 sided
Secondary
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
Population: From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 14.8 units on a scale | Standard Deviation 10.2 |
| Bipedicular Kyphoplasty Group | Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 14.1 units on a scale | Standard Deviation 9.3 |
p-value: 0.9t-test, 2 sided
Secondary
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
Population: From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 8.1 units on a scale | Standard Deviation 11.2 |
| Bipedicular Kyphoplasty Group | Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 6.7 units on a scale | Standard Deviation 9.4 |
p-value: 0.36t-test, 2 sided
Secondary
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
Population: From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 3.7 units on a scale | Standard Deviation 1.9 |
| Bipedicular Kyphoplasty Group | Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 3.5 units on a scale | Standard Deviation 2 |
p-value: 0.87t-test, 2 sided
Secondary
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
Population: From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 11.2 units on a scale | Standard Deviation 2.3 |
| Bipedicular Kyphoplasty Group | Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 8.1 units on a scale | Standard Deviation 3.4 |
p-value: 0.17t-test, 2 sided
Secondary
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
Population: From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 4.3 units on a scale | Standard Deviation 2.6 |
| Bipedicular Kyphoplasty Group | Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups | 3.9 units on a scale | Standard Deviation 2.8 |
p-value: 0.67t-test, 2 sided
Secondary
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
Population: Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty | 4.80 percent change | Standard Deviation 4 |
| Bipedicular Kyphoplasty Group | Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty | 4.70 percent change | Standard Deviation 4.6 |
p-value: 0.93t-test, 2 sided
Secondary
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
Population: Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unipedicular Kyphoplasty | Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty | 17.8 percent change | Standard Deviation 12.8 |
| Bipedicular Kyphoplasty Group | Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty | 13.7 percent change | Standard Deviation 8.9 |
p-value: 0.24t-test, 2 sided