Tibial Fractures
Conditions
Keywords
Tibia
Brief summary
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
Detailed description
A randomized, placebo controlled, clinical trial to evaluate the safety and efficacy of low-intensity, pulsed ultrasound, applied to tibial fractures treated with intramedullary nailing.
Interventions
DEVICEExogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
DEVICESham
sham device identical to active device with the exception of administration of ultrasound
Sponsors
McMaster University
Clinical Advances Through Research and Information Translation
Bioventus LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females age 18 years or older * Have an open or closed tibial fracture amenable to intramedullary nail fixation
Exclusion criteria
* Tibial fracture associated with a vascular injury requiring repair * Pilon fractures * Tibial fractures that extend into the joint and require reduction * Pathologic fractures • Bilateral tibial fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) | Over 365 days | Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best |
| Time (Days) to Radiographic Healing of Tibial Fractures | over 365 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Compliance | 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) | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exogen 4000+ Single arm, Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS) | 250 |
| 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 | 251 |
| Total | 501 |
Baseline characteristics
| Characteristic | Exogen 4000+ | Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 12 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 244 Participants | 239 Participants | 483 Participants |
| Age, Continuous | 37.1 years STANDARD_DEVIATION 13.2 | 39.1 years STANDARD_DEVIATION 14.6 | 38.3 years STANDARD_DEVIATION 13.9 |
| Region of Enrollment Canada | 82 participants | 85 participants | 167 participants |
| Region of Enrollment United States | 168 participants | 166 participants | 334 participants |
| Sex: Female, Male Female | 81 Participants | 75 Participants | 156 Participants |
| Sex: Female, Male Male | 169 Participants | 176 Participants | 345 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 98 / 250 | 97 / 251 |
| serious Total, serious adverse events | 3 / 250 | 5 / 251 |
Outcome results
Primary
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
Time frame: Over 365 days
Population: Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Exogen 4000+ | 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 |
| Sham | Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) | -7.5 units on a scale |
Primary
Time (Days) to Radiographic Healing of Tibial Fractures
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
Time frame: over 365 days
Population: Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exogen 4000+ | Time (Days) to Radiographic Healing of Tibial Fractures | 130 days |
| Sham | Time (Days) to Radiographic Healing of Tibial Fractures | 133 days |
Other Pre-specified
Treatment Compliance
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exogen 4000+ | Treatment Compliance | 44.6 percentage of compliant participants |
| Sham | Treatment Compliance | 42.3 percentage of compliant participants |