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The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xpedeâ„¢ Bone Cement | Experimental | The subjects in this group will be injected the Xpedeâ„¢ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body. |
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| Mendec Spine Bone Cement | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpedeâ„¢ Bone Cement | Device | Xpedeâ„¢ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline and 6 months |
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline, 1 day, and 3 months |
| The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou university | Zhengzhou | Henan | China | |||
| Hunan provincial people's hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xpedeâ„¢ Bone Cement | The subjects in this group will be injected the Xpedeâ„¢ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body. Xpedeâ„¢ Bone Cement: Xpedeâ„¢ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xpedeâ„¢ Bone Cement | The subjects in this group will be injected the Xpedeâ„¢ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body. Xpedeâ„¢ Bone Cement: Xpedeâ„¢ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Mean | Standard Deviation | score | Baseline and 6 months |
|
The mean (±sd) total duration of study exposure was 196.3±49.49 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xpedeâ„¢ Bone Cement | The subjects in this group will be injected the Xpedeâ„¢ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body. Xpedeâ„¢ Bone Cement: Xpedeâ„¢ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple organ failure | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Zhang | Medtronic | 86+18612318110 | jane.zhang7@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2018 | Sep 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2021 | Sep 22, 2022 | SAP_001.pdf |
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| Mendec Spine Bone Cement | Device | 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. |
|
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). |
| Baseline, 1 day, 3 months, and 6 months |
| 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. | Baseline, 1 day, 3 months, and 6 months |
| 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。 | 1 day, 3 months, and 6 months |
| 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. | Baseline, 1 day and 3 months |
| Number of Participants With Adverse Events Reported Through 6 Months | Adverse events reported through 6 months, in particular, the following events will be reported:
| 6 months |
| Changsha |
| Hunan |
| China |
| The first affiliated hospital of Suzhou university | Suzhou | Jiangsu | China |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | degree | Baseline and 6 months |
|
|
|
| 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." | Posted | Least Squares Mean | 95% Confidence Interval | score | Baseline, 1 day, and 3 months |
|
|
|
| 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). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 1 day, 3 months, and 6 months |
|
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 1 day, 3 months, and 6 months |
|
|
|
| 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。 | Posted | Least Squares Mean | 95% Confidence Interval | millimetre | 1 day, 3 months, and 6 months |
|
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | degree | Baseline, 1 day and 3 months |
|
|
|
| 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:
| Posted | Count of Participants | Participants | 6 months |
|
|
|
| 2 |
| 89 |
| 1 |
| 89 |
| 12 |
| 89 |
| EG001 | 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. | 1 | 91 | 1 | 91 | 7 | 91 |
| Post-operative recurrence of right breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| The change of ODI score from baseline 1 day |
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| The change of SF-36(MCS)from baseline at 1 day |
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| The change of SF-36(PCS)from baseline at 6 months |
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| The change of SF-36(PCS)from baseline at 3 months |
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| The change of SF-36(PCS)from baseline at 1 day |
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| Change in vertebral body height (Anterior height) restoration at 1 day |
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| Change in vertebral body height (Mid-vertebral height) restoration at 1 day |
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| Change in vertebral body height (Mid-vertebral height) restoration at 3 months |
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| Change in vertebral body height (Mid-vertebral height) restoration at 6 months |
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| Change in vertebral body height (Posterior height) restoration at 1 day |
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| Change in vertebral body height (Posterior height) restoration at 3 months |
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| Change in vertebral body height (Posterior height) restoration at 6 months |
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