Trial Outcomes & Findings for Vertebroplasty for the Treatment of Fractures Due to Osteoporosis (NCT NCT00068822)
NCT ID: NCT00068822
Last Updated: 2012-09-27
Results Overview
Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.
COMPLETED
PHASE3
131 participants
1 month after procedure
2012-09-27
Participant Flow
Participants were enrolled at five centers in the U.S., five centers in the United Kingdom and one center in Australia.
Participant milestones
| Measure |
Vertebroplasty, Then Control
Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate \[PMMA\] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
|
Control, Then Vertebroplasty
Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate \[PMMA\] into vertebral compression fracture).
|
|---|---|---|
|
First Randomized Intervention
STARTED
|
68
|
63
|
|
First Randomized Intervention
COMPLETED
|
67
|
61
|
|
First Randomized Intervention
NOT COMPLETED
|
1
|
2
|
|
Optional Crossover Intervention
STARTED
|
9
|
29
|
|
Optional Crossover Intervention
Crossover at Month 1
|
1
|
2
|
|
Optional Crossover Intervention
Crossover at Month 3
|
8
|
27
|
|
Optional Crossover Intervention
COMPLETED
|
9
|
29
|
|
Optional Crossover Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vertebroplasty, Then Control
Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate \[PMMA\] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
|
Control, Then Vertebroplasty
Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate \[PMMA\] into vertebral compression fracture).
|
|---|---|---|
|
First Randomized Intervention
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Baseline characteristics by cohort
| Measure |
Vertebroplasty
n=68 Participants
Participants will receive percutaneous vertebroplasty
|
Control Group
n=63 Participants
Participants will receive partial vertebroplasty without PMMA
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
73.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
73.84 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
RDQ Score at baseline
|
16.6 Units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
17.5 Units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
17.05 Units on a scale
STANDARD_DEVIATION 3.98 • n=5 Participants
|
|
Average pain intensity during past 24 hours at baseline
|
6.9 Units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
7.2 Units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
7.02 Units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
SF-36 score; summary physical component at baseline
|
25.3 Units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
25.3 Units on a scale
STANDARD_DEVIATION 7.3 • n=7 Participants
|
25.3 Units on a scale
STANDARD_DEVIATION 7.55 • n=5 Participants
|
|
SF-36 score; summary mental component at baseline
|
44.8 Units on a scale
STANDARD_DEVIATION 11.8 • n=5 Participants
|
41.5 Units on a scale
STANDARD_DEVIATION 14.1 • n=7 Participants
|
43.21 Units on a scale
STANDARD_DEVIATION 13.03 • n=5 Participants
|
|
Pain Frequency Index Score at baseline
|
3.0 Units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.1 Units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.04 Units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Pain Bothersome Index score at baseline
|
2.9 Units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.1 Units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.98 Units on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
EQ-SD Score at baseline
|
0.57 Units on a scale
STANDARD_DEVIATION 0.18 • n=5 Participants
|
0.54 Units on a scale
STANDARD_DEVIATION 0.23 • n=7 Participants
|
0.55 Units on a scale
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
SOF-ADL Score at baseline
|
10.0 Units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
10.3 Units on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
10.14 Units on a scale
STANDARD_DEVIATION 3.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after procedurePopulation: 68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.
Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.
Outcome measures
| Measure |
Vertebroplasty
n=67 Participants
Participants will receive percutaneous vertebroplasty
|
Control Group
n=61 Participants
Participants will receive partial vertebroplasty without PMMA
|
|---|---|---|
|
Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month
|
12.0 units on a scale
Standard Deviation 6.3
|
13.0 units on a scale
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.
Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.
Outcome measures
| Measure |
Vertebroplasty
n=67 Participants
Participants will receive percutaneous vertebroplasty
|
Control Group
n=61 Participants
Participants will receive partial vertebroplasty without PMMA
|
|---|---|---|
|
Patient's Rating of Average Pain at 1 Month
|
3.9 units on a scale
Standard Deviation 2.9
|
4.6 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Month 1Population: 68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.
Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain). European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL. Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability.
Outcome measures
| Measure |
Vertebroplasty
n=67 Participants
Participants will receive percutaneous vertebroplasty
|
Control Group
n=61 Participants
Participants will receive partial vertebroplasty without PMMA
|
|---|---|---|
|
Patient Well-being at 1 Month
SF-36 summary physical component
|
29.7 units on a scale
Standard Deviation 9.6
|
28.7 units on a scale
Standard Deviation 8.0
|
|
Patient Well-being at 1 Month
SF-36 summary mental component
|
46.9 units on a scale
Standard Deviation 12.0
|
45.6 units on a scale
Standard Deviation 14.8
|
|
Patient Well-being at 1 Month
Pain frequency index score
|
2.1 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.1
|
|
Patient Well-being at 1 Month
Pain bothersome index score
|
1.9 units on a scale
Standard Deviation 1.1
|
2.1 units on a scale
Standard Deviation 1.1
|
|
Patient Well-being at 1 Month
EQ-5D score
|
0.70 units on a scale
Standard Deviation 0.18
|
0.64 units on a scale
Standard Deviation 0.20
|
|
Patient Well-being at 1 Month
SOF-ADL score
|
7.7 units on a scale
Standard Deviation 3.7
|
8.2 units on a scale
Standard Deviation 3.6
|
Adverse Events
Vertebroplasty
Control Group
Serious adverse events
| Measure |
Vertebroplasty
n=68 participants at risk
Participants will receive percutaneous vertebroplasty
|
Control Group
n=61 participants at risk
Participants will receive partial vertebroplasty without PMMA
|
|---|---|---|
|
Injury, poisoning and procedural complications
Surgical injury
|
1.5%
1/68 • Number of events 1 • 12 months from baseline
|
0.00%
0/61 • 12 months from baseline
|
|
Cardiac disorders
Tachycardia and rigors
|
0.00%
0/68 • 12 months from baseline
|
1.6%
1/61 • Number of events 1 • 12 months from baseline
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place