Trial Outcomes & Findings for Xpede Clinical Study (NCT NCT03730207)
NCT ID: NCT03730207
Last Updated: 2023-01-10
Results Overview
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."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
91
|
|
Overall Study
COMPLETED
|
83
|
88
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xpede Clinical Study
Baseline characteristics by cohort
| Measure |
Xpede™ Bone Cement
n=89 Participants
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.
|
Mendec Spine Bone Cement
n=91 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.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 5.59 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 7.06 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 6.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
89 participants
n=5 Participants
|
91 participants
n=7 Participants
|
180 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsNRS 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."
Outcome measures
| Measure |
Xpede™ Bone Cement
n=83 Participants
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.
|
Mendec Spine Bone Cement
n=88 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.
|
|---|---|---|
|
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
|
-4.2 score
Standard Deviation 2.86
|
-4.4 score
Standard Deviation 2.76
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsVertebral 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.
Outcome measures
| Measure |
Xpede™ Bone Cement
n=71 Participants
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.
|
Mendec Spine Bone Cement
n=79 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.
|
|---|---|---|
|
The Change of Index Vertebral Body Angle From Baseline at 6 Months
|
-0.869 degree
Interval -1.817 to 0.078
|
-0.952 degree
Interval -1.878 to -0.027
|
SECONDARY outcome
Timeframe: Baseline, 1 day, and 3 monthsNRS 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."
Outcome measures
| Measure |
Xpede™ Bone Cement
n=89 Participants
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.
|
Mendec Spine Bone Cement
n=91 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.
|
|---|---|---|
|
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
Interval -3.5 to -2.3
|
-2.3 score
Interval -2.9 to -1.7
|
|
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
Interval -4.2 to -3.1
|
-3.8 score
Interval -4.4 to -3.3
|
SECONDARY outcome
Timeframe: Baseline, 1 day, 3 months, and 6 monthsODI 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).
Outcome measures
| Measure |
Xpede™ Bone Cement
n=89 Participants
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.
|
Mendec Spine Bone Cement
n=91 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.
|
|---|---|---|
|
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
Interval -31.714 to -21.1
|
-29.108 score on a scale
Interval -34.331 to -23.885
|
|
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
Interval -31.714 to -21.1
|
-29.108 score on a scale
Interval -34.331 to -23.885
|
|
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
Interval -7.297 to 3.782
|
1.746 score on a scale
Interval -3.698 to 7.19
|
SECONDARY outcome
Timeframe: Baseline, 1 day, 3 months, and 6 monthsThe 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.
Outcome measures
| Measure |
Xpede™ Bone Cement
n=89 Participants
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.
|
Mendec Spine Bone Cement
n=91 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.
|
|---|---|---|
|
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
Interval -0.106 to 7.668
|
-1.436 score on a scale
Interval -5.19 to 2.317
|
|
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
Interval 2.018 to 9.462
|
0.086 score on a scale
Interval -3.498 to 3.671
|
|
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
Interval -2.591 to 3.89
|
0.809 score on a scale
Interval -2.293 to 3.911
|
|
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
Interval 4.838 to 10.872
|
9.683 score on a scale
Interval 6.725 to 12.641
|
|
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
Interval 2.783 to 8.697
|
6.504 score on a scale
Interval 3.605 to 9.404
|
|
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
Interval -5.596 to -0.611
|
-3.654 score on a scale
Interval -6.097 to -1.211
|
SECONDARY outcome
Timeframe: 1 day, 3 months, and 6 monthsVertebral 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。
Outcome measures
| Measure |
Xpede™ Bone Cement
n=89 Participants
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.
|
Mendec Spine Bone Cement
n=91 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.
|
|---|---|---|
|
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
Interval -5.348 to -3.195
|
-4.429 millimetre
Interval -5.492 to -3.366
|
|
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
Interval -5.04 to -2.859
|
-4.154 millimetre
Interval -5.234 to -3.074
|
|
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
Interval -3.597 to -1.432
|
-2.738 millimetre
Interval -3.809 to -1.666
|
|
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
Interval -2.375 to -1.531
|
-2.845 millimetre
Interval -3.679 to -2.011
|
|
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
Interval -4.61 to -2.844
|
-3.979 millimetre
Interval -4.85 to -3.108
|
|
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
Interval -4.255 to -2.597
|
-3.603 millimetre
Interval -4.418 to -2.788
|
|
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
Interval -0.912 to 0.656
|
-0.613 millimetre
Interval -1.387 to 0.16
|
|
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
Interval -1.682 to 0.041
|
-1.579 millimetre
Interval -2.426 to -0.732
|
|
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
Interval -1.628 to -0.096
|
-1.451 millimetre
Interval -2.201 to -0.702
|
SECONDARY outcome
Timeframe: Baseline, 1 day and 3 monthsVertebral 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.
Outcome measures
| Measure |
Xpede™ Bone Cement
n=86 Participants
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.
|
Mendec Spine Bone Cement
n=90 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.
|
|---|---|---|
|
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
Interval -2.693 to -0.727
|
-1.662 degree
Interval -2.629 to -0.695
|
|
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
Interval -3.629 to -1.848
|
-2.375 degree
Interval -3.254 to -1.496
|
SECONDARY outcome
Timeframe: 6 monthsAdverse 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;
Outcome measures
| Measure |
Xpede™ Bone Cement
n=89 Participants
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.
|
Mendec Spine Bone Cement
n=91 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.
|
|---|---|---|
|
Number of Participants With Adverse Events Reported Through 6 Months
|
28 Participants
|
32 Participants
|
Adverse Events
Xpede™ Bone Cement
Serious events: 1 serious events
Other events: 12 other events
Deaths: 2 deaths
Mendec Spine Bone Cement
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Xpede™ Bone Cement
n=89 participants at risk
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.
|
Mendec Spine Bone Cement
n=91 participants at risk
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.
|
|---|---|---|
|
General disorders
Multiple organ failure
|
1.1%
1/89 • Number of events 1 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
0.00%
0/91 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post-operative recurrence of right breast cancer
|
1.1%
1/89 • Number of events 1 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
0.00%
0/91 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/89 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
3.1%
1/32 • Number of events 1 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
Other adverse events
| Measure |
Xpede™ Bone Cement
n=89 participants at risk
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.
|
Mendec Spine Bone Cement
n=91 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
13.5%
12/89 • Number of events 12 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
7.7%
7/91 • Number of events 7 • The mean (±sd) total duration of study exposure was 196.3±49.49 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER