The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
1\. STUDY OBJECTIVES AND ENDPOINTS 1.1. Objectives The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer. 1.2. Primary Endpoint The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment. 1.3. Secondary Endpoints The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit. Safety: * Rate of study treatment-related adverse events * Change in neurological status Clinical: * Change in functional status as assessed with Karnofsky Performance Scale * Change in quality of life as assessed by the SF-36v2™ Health Survey * Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS) * Change in back-pain analgesics used * Change in ambulation status * Changes in activities of daily living * Time to treatment failure Radiographic: * Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory * Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.
Valley Radiology Inc., UCSD
Escondido, California, United States
Boulder Neurosurgical Associates
Boulder, Colorado, United States
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)
Time frame: Baseline and 1 Month
Change in Roland-Morris Disability Questionnaire Score
Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Functional Status Assessed With the Karnofsky Performance Scale
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Time frame: Baseline and 1 month
Change in Functional Status Assessed With the Karnofsky Performance Scale
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Back Pain
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline and 1 month
Change in Back Pain
Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Sibley Memorial Hospital
Chevy Chase, Maryland, United States
Greater Oncology Associates
Silver Spring, Maryland, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
St. Vincent's Hospital
Fitzroy, Victoria, Australia
...and 10 more locations
Change in Quality of Life.
The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Time frame: Baseline and 1 month
Change in Quality of Life
The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Time frame: Baseline and 1 month
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Time frame: Baseline and 1 month
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Time frame: Baseline and 1 month
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Ambulatory Status Change From Baseline to One Month
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Time frame: 1 month
Ambulatory Status Change
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Time frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Time frame: Baseline and 1 month
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Time frame: Baseline, post-operation, 1 month, and 12 months
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Time frame: Baseline and 1 month
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Time frame: Baseline, post-operation, 1 month, and 12 months
Back Pain Analgesics Used
Time frame: Baseline, 7 days, and 1 month
Back Pain Analgesics Used
Time frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Change in Neurology Status From Baseline (Motor Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Time frame: 1 month
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Time frame: 1 month, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Sensory Examination)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Time frame: 1 month
Change in Neurological Status From Baseline (Sensory Examination)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Time frame: 1 months, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Reflex Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Time frame: 1 month
Change in Neurological Status From Baseline (Reflex Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Time frame: 1 months, 3 months, 6 months, and 12 months
Change in Neurological Status From Baseline (Limb Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Time frame: 1 month
Change in Neurological Status From Baseline (Limb Strength)
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Time frame: 1 months, 3 months, 6 months, and 12 months
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
The study treatment-related AEs were defined as follows: 1. Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. 2. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. 3. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. 4. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Time frame: 1 month
Rate of Study Treatment-related Adverse Events Till Study Completion
The study treatment-related AEs were defined as follows: 1. Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. 2. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. 3. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. 4. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Time frame: 12 months
Rate of Subsequent Vertebral Body Fractures
Time frame: 1 month
Rate of Subsequent Vertebral Body Fractures
Based on patients with at least 7 analyzable vertebrae.
Time frame: 1 month and 12 months