Trial Outcomes & Findings for Calcium Sulfate Spacer in Open Tibia Fractures (NCT NCT03042546)
NCT ID: NCT03042546
Last Updated: 2023-02-10
Results Overview
Radiographic healing at one year with no additional surgery
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
One Year
Results posted on
2023-02-10
Participant Flow
Only enrolled patient was not randomized
Participant milestones
| Measure |
Calcium Sulphate
Calcium Sulfate: Calcium Sulfate with abx will be used in the defect
|
PMMA
PMMA: PMMA with abx will be used in the defect
|
Nothing
No treatment: The defect will not be treated
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Calcium Sulfate Spacer in Open Tibia Fractures
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: One YearPopulation: project was abandoned as PI left institution
Radiographic healing at one year with no additional surgery
Outcome measures
Outcome data not reported
Adverse Events
Calcium Sulphate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PMMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nothing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place