Closed Transverse Fracture of Shaft of Tibia
Conditions
Brief summary
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.
Interventions
DEVICEConventional Compression
Method of Nail fitting
DEVICEStandard Backslapping
Method of Nail fitting
DEVICEDynamic Locking with Backslapping
Method of Nail fitting
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant Blinding
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Closed Tibia Shaft Fracture Treated with an IMN
Exclusion criteria
* Unable to consent due to language * Unlikely to follow-up for one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of Tibia Fracture by Radiographic Exam | One Year | Healing of Tibia Fracture by radiographic exam |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Compression Nail will be seated using conventional compression technique
Conventional Compression: Method of Nail fitting | 1 |
| Standard Backslapping Nail will be seated using standard backslapping technique
Standard Backslapping: Method of Nail fitting | 4 |
| Dynamic Locking With Backslapping Nail will be seated using backslapping with dynamic locking
Dynamic Locking with Backslapping: Method of Nail fitting | 1 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | MD left program | 1 | 4 | 1 |
Baseline characteristics
| Characteristic | Conventional Compression | Dynamic Locking With Backslapping | Total | Standard Backslapping |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 6 Participants | 4 Participants |
| Age, Continuous | 63 years | 37 years | 42 years | 37 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 4 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 4 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 4 | 0 / 1 |
Outcome results
Primary
Healing of Tibia Fracture by Radiographic Exam
Healing of Tibia Fracture by radiographic exam
Time frame: One Year
Population: MD left institution project closed data not collected