Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder), Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)
Conditions
Brief summary
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Interventions
DEVICEXpede™ Bone Cement
Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
DEVICEMendec Spine Bone Cement
Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice. 2. Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration. 3. Subjects are at least 18 and ≤80 years old .
Exclusion criteria
1. Subject has a local or systemic infection. 2. Subject has pains caused by other spine disease than painful pathological vertebral compression fracture. 3. Subject has a medical condition with less than 1 year of life expectancy. 4. Subject is grossly obese, i.e. BMI≥40. 5. Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision. 6. Subject has an allergy or an intolerance to bone cement component. 7. Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable. 8. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor. 9. Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence. 10. Subjects with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative | Baseline and 6 months | NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. |
| The Change of Index Vertebral Body Angle From Baseline at 6 Months | Baseline and 6 months | Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | Baseline, 1 day, 3 months, and 6 months | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life. |
| Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | 1 day, 3 months, and 6 months | Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters. Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。 |
| The Change of NRS Score From Baseline at 1 Day and 3 Months | Baseline, 1 day, and 3 months | NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. |
| Number of Participants With Adverse Events Reported Through 6 Months | 6 months | Adverse events reported through 6 months, in particular, the following events will be reported: * Bone Cement Implantation Syndrome; * Bone Cement leakage; * Vertebral body compression fracture; * Adjacent vertebral body fracture; |
| Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months | Baseline, 1 day and 3 months | Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body. |
| The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | Baseline, 1 day, 3 months, and 6 months | ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xpede™ Bone Cement The subjects in this group will be injected the Xpede™ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.
Xpede™ Bone Cement: Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. | 89 |
| Mendec Spine Bone Cement The subjects in this group will be injected the Mendec Spine Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.
Mendec Spine Bone Cement: Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. | 91 |
| Total | 180 |
Baseline characteristics
| Characteristic | Xpede™ Bone Cement | Total | Mendec Spine Bone Cement |
|---|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 5.59 | 67.6 years STANDARD_DEVIATION 6.38 | 67.1 years STANDARD_DEVIATION 7.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 89 Participants | 180 Participants | 91 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 89 participants | 180 participants | 91 participants |
| Sex: Female, Male Female | 74 Participants | 148 Participants | 74 Participants |
| Sex: Female, Male Male | 15 Participants | 32 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 89 | 1 / 91 |
| other Total, other adverse events | 12 / 89 | 7 / 91 |
| serious Total, serious adverse events | 1 / 89 | 1 / 91 |
Outcome results
Primary
The Change of Index Vertebral Body Angle From Baseline at 6 Months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Time frame: Baseline and 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Xpede™ Bone Cement | The Change of Index Vertebral Body Angle From Baseline at 6 Months | -0.869 degree |
| Mendec Spine Bone Cement | The Change of Index Vertebral Body Angle From Baseline at 6 Months | -0.952 degree |
Primary
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xpede™ Bone Cement | The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative | -4.2 score | Standard Deviation 2.86 |
| Mendec Spine Bone Cement | The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative | -4.4 score | Standard Deviation 2.76 |
Secondary
Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Time frame: Baseline, 1 day and 3 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Xpede™ Bone Cement | Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months | Change in Vertebral body angle from baseline at 3 months | -1.710 degree |
| Xpede™ Bone Cement | Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months | Change in Vertebral body angle from baseline at 1 day | -2.739 degree |
| Mendec Spine Bone Cement | Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months | Change in Vertebral body angle from baseline at 3 months | -1.662 degree |
| Mendec Spine Bone Cement | Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months | Change in Vertebral body angle from baseline at 1 day | -2.375 degree |
Secondary
Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months
Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters. Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。
Time frame: 1 day, 3 months, and 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Anterior height) restoration at 3 months | -3.949 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Mid-vertebral height) restoration at 6 months | -3.426 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Mid-vertebral height) restoration at 1 day | -2.375 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Posterior height) restoration at 1 day | -0.128 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Anterior height) restoration at 1 day | -2.514 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Posterior height) restoration at 3 months | -0.821 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Mid-vertebral height) restoration at 3 months | -3.727 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Posterior height) restoration at 6 months | -0.862 millimetre |
| Xpede™ Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Anterior height) restoration at 6 months | -4.271 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Posterior height) restoration at 6 months | -1.451 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Anterior height) restoration at 6 months | -4.429 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Anterior height) restoration at 3 months | -4.154 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Anterior height) restoration at 1 day | -2.738 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Mid-vertebral height) restoration at 1 day | -2.845 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Mid-vertebral height) restoration at 3 months | -3.979 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Mid-vertebral height) restoration at 6 months | -3.603 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Posterior height) restoration at 1 day | -0.613 millimetre |
| Mendec Spine Bone Cement | Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months | Change in vertebral body height (Posterior height) restoration at 3 months | -1.579 millimetre |
Secondary
Number of Participants With Adverse Events Reported Through 6 Months
Adverse events reported through 6 months, in particular, the following events will be reported: * Bone Cement Implantation Syndrome; * Bone Cement leakage; * Vertebral body compression fracture; * Adjacent vertebral body fracture;
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xpede™ Bone Cement | Number of Participants With Adverse Events Reported Through 6 Months | 28 Participants |
| Mendec Spine Bone Cement | Number of Participants With Adverse Events Reported Through 6 Months | 32 Participants |
Secondary
The Change of NRS Score From Baseline at 1 Day and 3 Months
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.
Time frame: Baseline, 1 day, and 3 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Xpede™ Bone Cement | The Change of NRS Score From Baseline at 1 Day and 3 Months | The change of NRS score from baseline at 1 day | -2.9 score |
| Xpede™ Bone Cement | The Change of NRS Score From Baseline at 1 Day and 3 Months | The change of NRS score from baseline at 3 months | -3.6 score |
| Mendec Spine Bone Cement | The Change of NRS Score From Baseline at 1 Day and 3 Months | The change of NRS score from baseline at 1 day | -2.3 score |
| Mendec Spine Bone Cement | The Change of NRS Score From Baseline at 1 Day and 3 Months | The change of NRS score from baseline at 3 months | -3.8 score |
Secondary
The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months
ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time frame: Baseline, 1 day, 3 months, and 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Xpede™ Bone Cement | The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | The change of ODI score from baseline 3 months | -26.407 score on a scale |
| Xpede™ Bone Cement | The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | The change of ODI score from baseline 6 months | -26.407 score on a scale |
| Xpede™ Bone Cement | The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | The change of ODI score from baseline 1 day | -1.757 score on a scale |
| Mendec Spine Bone Cement | The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | The change of ODI score from baseline 3 months | -29.108 score on a scale |
| Mendec Spine Bone Cement | The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | The change of ODI score from baseline 6 months | -29.108 score on a scale |
| Mendec Spine Bone Cement | The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months | The change of ODI score from baseline 1 day | 1.746 score on a scale |
Secondary
The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life.
Time frame: Baseline, 1 day, 3 months, and 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Xpede™ Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(MCS)from baseline at 6 months | 3.781 score on a scale |
| Xpede™ Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(MCS) from baseline at 3 months | 5.740 score on a scale |
| Xpede™ Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(MCS)from baseline at 1 day | 0.650 score on a scale |
| Xpede™ Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(PCS)from baseline at 6 months | 7.855 score on a scale |
| Xpede™ Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(PCS)from baseline at 3 months | 5.740 score on a scale |
| Xpede™ Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(PCS)from baseline at 1 day | -3.104 score on a scale |
| Mendec Spine Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(PCS)from baseline at 3 months | 6.504 score on a scale |
| Mendec Spine Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(MCS)from baseline at 6 months | -1.436 score on a scale |
| Mendec Spine Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(PCS)from baseline at 6 months | 9.683 score on a scale |
| Mendec Spine Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(MCS) from baseline at 3 months | 0.086 score on a scale |
| Mendec Spine Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(PCS)from baseline at 1 day | -3.654 score on a scale |
| Mendec Spine Bone Cement | The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months | The change of SF-36(MCS)from baseline at 1 day | 0.809 score on a scale |