Open tíbia Fracture With Sub-segmental Bone Loss
Conditions
Brief summary
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
Interventions
DRUGCalcium Sulfate
Calcium Sulfate with abx will be used in the defect
DRUGPMMA
PMMA with abx will be used in the defect
OTHERNo treatment
The defect will not be treated
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients are blinded
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open tibia shaft fracture treated with an IMN
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Nonunion | One Year | Radiographic healing at one year with no additional surgery |
Countries
United States
Participant flow
Pre-assignment details
Only enrolled patient was not randomized
Participants by arm
| Arm | Count |
|---|---|
| Calcium Sulphate Calcium Sulfate: Calcium Sulfate with abx will be used in the defect | 0 |
| PMMA PMMA: PMMA with abx will be used in the defect | 0 |
| Nothing No treatment: The defect will not be treated | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients With a Nonunion
Radiographic healing at one year with no additional surgery
Time frame: One Year
Population: project was abandoned as PI left institution