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Study was terminated due to futility
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| Name | Class |
|---|---|
| McMaster University | OTHER |
| Clinical Advances Through Research and Information Translation | UNKNOWN |
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The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exogen 4000+ | Active Comparator | Single arm, Exogen 4000+ |
|
| Sham | Sham Comparator | Single arm, sham (identical device with the exception of administration of ultrasound). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exogen 4000+ | Device | Low-intensity pulsed ultrasound (LIPUS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Over 365 days |
| 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 | over 365 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General/Dept of Orthopedic Surgery | San Francisco | California | 94110 | United States | ||
| Florida Orthopedic Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33196584 | Derived | Findakli F, Busse JW, Schemitsch EH, Lonn E, Farrokhyar F, Bhandari M; and the TRUST Investigators. Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study. Clin Orthop Relat Res. 2021 Apr 1;479(4):805-813. doi: 10.1097/CORR.0000000000001573. | |
| 27797787 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exogen 4000+ | Single arm, Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham | Device | sham device identical to active device with the exception of administration of ultrasound |
|
|
| Tampa |
| Florida |
| 33606 |
| United States |
| OrthoIndy | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky | Lexington | Kentucky | 50436 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Insall Scott Kelly Institute | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Orthopedic Specialtiy Associates | Fort Worth | Texas | 76104 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Vancouver Coastal Health | Vancouver | British Columbia | V5Z 1M9 | Canada |
| QE II Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Derived |
| TRUST Investigators writing group; Busse JW, Bhandari M, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P 3rd, Leung KS, Heels-Ansdell D, Makosso-Kallyth S, Della Rocca GJ, Jones CB, Guyatt GH. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016 Oct 25;355:i5351. doi: 10.1136/bmj.i5351. |
| 24898987 | Derived | Busse JW, Bhandari M, Einhorn TA, Heckman JD, Leung KS, Schemitsch E, Tornetta P 3rd, Walter SD, Guyatt GH. Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. 2014 Jun 4;15:206. doi: 10.1186/1745-6215-15-206. |
| 22050862 | Derived | Dijkman BG, Busse JW, Walter SD, Bhandari M; TRUST Investigators. The impact of clinical data on the evaluation of tibial fracture healing. Trials. 2011 Nov 3;12:237. doi: 10.1186/1745-6215-12-237. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exogen 4000+ | Single arm, Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | 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 | Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Over 365 days |
|
|
| ||||||||||||||||||||||||||||
| 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 | Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays. | Posted | Median | Inter-Quartile Range | days | over 365 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. | FAS with compliance data (subjects who returned the device) | Posted | Number | percentage of compliant participants | 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) |
|
|
up to 2 years
no standardized coding dictionary used
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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 | Exogen 4000+ | Single arm, active Exogen 4000+ ultrasound bone healing system Low-intensity pulsed ultrasound (LIPUS) | 3 | 250 | 98 | 250 | ||
| EG001 | Sham | 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 | 5 | 251 | 97 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute chest pain | Cardiac disorders | Non-systematic Assessment | abnormal troponin level and nausea Resulted in hospitalization Not related to device |
| |
| Allergic reaction | Immune system disorders | Non-systematic Assessment | Resulted in hospitalization Not related to device |
| |
| Infection, tissue | Infections and infestations | Non-systematic Assessment | Resulted in hospitalization, was a life threatening situation, necessitated medical surgical intervention to preclude primary impairment of body function or permanent damage to a body structure. Not related to device. |
| |
| Renal dysfunction (creatinine 2x BL level | Renal and urinary disorders | Non-systematic Assessment | Resulted in hospitalization Not related to device |
| |
| Broken screw | Surgical and medical procedures | Non-systematic Assessment | Resulted in hospitalization Not related to device |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | tendonitis of hip; resulted in hospitalization |
| |
| sternal wire closure disruption | Cardiac disorders | Non-systematic Assessment | resulted in hospitalization |
| |
| cough, vomiting, leukocytosis, increased troponin | Gastrointestinal disorders | Non-systematic Assessment | possible gastroenteritis resulted in hospitalization |
| |
| infection tissue | Infections and infestations | Non-systematic Assessment | cellulitis; resulted in hospitalization |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | Blood and lymphatic system disorders | Non-systematic Assessment | Edema of left lower extremity |
| |
| Other, not listed on AE form | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Infection, tissue | Infections and infestations | Systematic Assessment |
| ||
| Wound complication | Infections and infestations | Systematic Assessment |
| ||
| accident/fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Non-union | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Other local event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain | Nervous system disorders | Non-systematic Assessment |
| ||
| Rash/redness at treated area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Poor Compliance: Protocol defined compliance as ≥18 minutes use per day. Devices have a treatment monitor that showed average compliance of 42.3% (sham) and 44.6% (active) in 80% of treatment days. Poor treatment adherence confounds results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Heeckt, MD (CMO) | Bioventus LLC | 1-800-396-4325 | peter.heeckt@bioventusglobal.com |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| >=65 years |
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| Male |
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| United States |
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