Trial Outcomes & Findings for Union Rate of Transverse Tibia Fracture (NCT NCT03042533)
NCT ID: NCT03042533
Last Updated: 2024-05-03
Results Overview
Healing of Tibia Fracture by radiographic exam
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
One Year
Results posted on
2024-05-03
Participant Flow
Participant milestones
| Measure |
Conventional Compression
Nail will be seated using conventional compression technique
Conventional Compression: Method of Nail fitting
|
Standard Backslapping
Nail will be seated using standard backslapping technique
Standard Backslapping: Method of Nail fitting
|
Dynamic Locking With Backslapping
Nail will be seated using backslapping with dynamic locking
Dynamic Locking with Backslapping: Method of Nail fitting
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Conventional Compression
Nail will be seated using conventional compression technique
Conventional Compression: Method of Nail fitting
|
Standard Backslapping
Nail will be seated using standard backslapping technique
Standard Backslapping: Method of Nail fitting
|
Dynamic Locking With Backslapping
Nail will be seated using backslapping with dynamic locking
Dynamic Locking with Backslapping: Method of Nail fitting
|
|---|---|---|---|
|
Overall Study
MD left program
|
1
|
4
|
1
|
Baseline Characteristics
Union Rate of Transverse Tibia Fracture
Baseline characteristics by cohort
| Measure |
Conventional Compression
n=1 Participants
Nail will be seated using conventional compression technique
Conventional Compression: Method of Nail fitting
|
Standard Backslapping
n=4 Participants
Nail will be seated using standard backslapping technique
Standard Backslapping: Method of Nail fitting
|
Dynamic Locking With Backslapping
n=1 Participants
Nail will be seated using backslapping with dynamic locking
Dynamic Locking with Backslapping: Method of Nail fitting
|
Total
n=6 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
37 years
n=7 Participants
|
37 years
n=5 Participants
|
42 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: MD left institution project closed data not collected
Healing of Tibia Fracture by radiographic exam
Outcome measures
Outcome data not reported
Adverse Events
Conventional Compression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Backslapping
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dynamic Locking With Backslapping
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