Trial Outcomes & Findings for Trial to Evaluate UltraSound in the Treatment of Tibial Fractures (NCT NCT00667849)
NCT ID: NCT00667849
Last Updated: 2015-12-08
Results Overview
Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
501 participants
Primary outcome timeframe
Over 365 days
Results posted on
2015-12-08
Participant Flow
Participant milestones
| Measure |
Exogen 4000+
Single arm, Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
|
Sham
Single arm, sham (identical to active device with the exception of administration of ultrasound)
Sham: sham device identical to active device with the exception of administration of ultrasound
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
251
|
|
Overall Study
COMPLETED
|
142
|
130
|
|
Overall Study
NOT COMPLETED
|
108
|
121
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Baseline characteristics by cohort
| Measure |
Exogen 4000+
n=250 Participants
Single arm, Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
|
Sham
n=251 Participants
Single arm, sham (identical to active device with the exception of administration of ultrasound).
Sham: sham device identical to active device with the exception of administration of ultrasound
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
244 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
483 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
82 participants
n=5 Participants
|
85 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=5 Participants
|
166 participants
n=7 Participants
|
334 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over 365 daysPopulation: Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.
Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
Outcome measures
| Measure |
Exogen 4000+
n=241 Participants
Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
|
Sham
n=242 Participants
Single arm, sham (identical to active device with the exception of administration of ultrasound)
|
|---|---|---|
|
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
|
-6.9 units on a scale
Interval -8.0 to -5.9
|
-7.5 units on a scale
Interval -8.6 to -6.5
|
PRIMARY outcome
Timeframe: over 365 daysPopulation: Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.
Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier
Outcome measures
| Measure |
Exogen 4000+
n=241 Participants
Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
|
Sham
n=242 Participants
Single arm, sham (identical to active device with the exception of administration of ultrasound)
|
|---|---|---|
|
Time (Days) to Radiographic Healing of Tibial Fractures
|
130 days
Interval 112.0 to 183.0
|
133 days
Interval 115.0 to 186.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)Population: FAS with compliance data (subjects who returned the device)
The percent of subjects who used the device greater than or equal to 18 minutes per day over 80% of the days in their treatment period.
Outcome measures
| Measure |
Exogen 4000+
n=213 Participants
Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
|
Sham
n=215 Participants
Single arm, sham (identical to active device with the exception of administration of ultrasound)
|
|---|---|---|
|
Treatment Compliance
|
44.6 percentage of compliant participants
|
42.3 percentage of compliant participants
|
Adverse Events
Exogen 4000+
Serious events: 3 serious events
Other events: 98 other events
Deaths: 0 deaths
Sham
Serious events: 5 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exogen 4000+
n=250 participants at risk
Single arm, active Exogen 4000+ ultrasound bone healing system
Low-intensity pulsed ultrasound (LIPUS)
|
Sham
n=251 participants at risk
Single arm, sham (identical to active device with the exception of administration of ultrasound)
Sham: device identical to active device with the exception of administration of ultrasound
|
|---|---|---|
|
Cardiac disorders
acute chest pain
|
0.00%
0/250 • up to 2 years
no standardized coding dictionary used
|
0.40%
1/251 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
|
Immune system disorders
Allergic reaction
|
0.40%
1/250 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
0.00%
0/251 • up to 2 years
no standardized coding dictionary used
|
|
Infections and infestations
Infection, tissue
|
0.40%
1/250 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
0.00%
0/251 • up to 2 years
no standardized coding dictionary used
|
|
Renal and urinary disorders
Renal dysfunction (creatinine 2x BL level
|
0.00%
0/250 • up to 2 years
no standardized coding dictionary used
|
0.40%
1/251 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
|
Surgical and medical procedures
Broken screw
|
0.40%
1/250 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
0.40%
1/251 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.40%
1/250 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
0.00%
0/251 • up to 2 years
no standardized coding dictionary used
|
|
Cardiac disorders
sternal wire closure disruption
|
0.00%
0/250 • up to 2 years
no standardized coding dictionary used
|
0.40%
1/251 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
|
Gastrointestinal disorders
cough, vomiting, leukocytosis, increased troponin
|
0.00%
0/250 • up to 2 years
no standardized coding dictionary used
|
0.40%
1/251 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
|
Infections and infestations
infection tissue
|
0.00%
0/250 • up to 2 years
no standardized coding dictionary used
|
0.40%
1/251 • Number of events 1 • up to 2 years
no standardized coding dictionary used
|
Other adverse events
| Measure |
Exogen 4000+
n=250 participants at risk
Single arm, active Exogen 4000+ ultrasound bone healing system
Low-intensity pulsed ultrasound (LIPUS)
|
Sham
n=251 participants at risk
Single arm, sham (identical to active device with the exception of administration of ultrasound)
Sham: device identical to active device with the exception of administration of ultrasound
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema
|
7.2%
18/250 • Number of events 18 • up to 2 years
no standardized coding dictionary used
|
6.0%
15/251 • Number of events 16 • up to 2 years
no standardized coding dictionary used
|
|
General disorders
Other, not listed on AE form
|
2.8%
7/250 • Number of events 7 • up to 2 years
no standardized coding dictionary used
|
8.4%
21/251 • Number of events 24 • up to 2 years
no standardized coding dictionary used
|
|
General disorders
Pain
|
3.2%
8/250 • Number of events 8 • up to 2 years
no standardized coding dictionary used
|
3.2%
8/251 • Number of events 8 • up to 2 years
no standardized coding dictionary used
|
|
Infections and infestations
Infection, tissue
|
2.4%
6/250 • Number of events 6 • up to 2 years
no standardized coding dictionary used
|
3.6%
9/251 • Number of events 9 • up to 2 years
no standardized coding dictionary used
|
|
Infections and infestations
Wound complication
|
2.8%
7/250 • Number of events 7 • up to 2 years
no standardized coding dictionary used
|
2.0%
5/251 • Number of events 5 • up to 2 years
no standardized coding dictionary used
|
|
Injury, poisoning and procedural complications
accident/fall
|
5.6%
14/250 • Number of events 15 • up to 2 years
no standardized coding dictionary used
|
2.8%
7/251 • Number of events 7 • up to 2 years
no standardized coding dictionary used
|
|
Musculoskeletal and connective tissue disorders
Non-union
|
3.2%
8/250 • Number of events 8 • up to 2 years
no standardized coding dictionary used
|
1.6%
4/251 • Number of events 5 • up to 2 years
no standardized coding dictionary used
|
|
Musculoskeletal and connective tissue disorders
Other local event
|
7.6%
19/250 • Number of events 19 • up to 2 years
no standardized coding dictionary used
|
8.0%
20/251 • Number of events 21 • up to 2 years
no standardized coding dictionary used
|
|
Nervous system disorders
Pain
|
19.2%
48/250 • Number of events 58 • up to 2 years
no standardized coding dictionary used
|
19.5%
49/251 • Number of events 63 • up to 2 years
no standardized coding dictionary used
|
|
Skin and subcutaneous tissue disorders
Rash/redness at treated area
|
4.0%
10/250 • Number of events 10 • up to 2 years
no standardized coding dictionary used
|
1.2%
3/251 • Number of events 3 • up to 2 years
no standardized coding dictionary used
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60