Fractures, Closed
Conditions
Brief summary
The purpose of this study is to evaluate patients with tibial plateau fractures.
Detailed description
The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins. Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.
Interventions
DEVICEAnterior pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
DEVICELateral pin placement
Laterally-placed (side of the leg) femoral external fixator pind
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and above (adult population) * All open and closed tibial plateau fractures
Exclusion criteria
* 17 years of age and less (pediatric population) * Quadriplegic patients * Vascular Injury to Extremity * Ipsilateral femur fractures * Ipsilateral Hip fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Strength | (admission, 6 weeks, 3 months, 6 months) 1 year | measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-anterior Pin Placement Anterior
Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins | 5 |
| 2-lateral Pin Placement Lateral
Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | 1-anterior Pin Placement | 2-lateral Pin Placement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 14 Participants |
| Region of Enrollment United States | 5 participants | 9 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 2 / 5 | 3 / 9 |
Outcome results
Primary
Quadriceps Strength
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
Time frame: (admission, 6 weeks, 3 months, 6 months) 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-anterior Pin Placement | Quadriceps Strength | 35.9 Nm | Standard Deviation 10.7 |
| 2-lateral Pin Placement | Quadriceps Strength | 39.6 Nm | Standard Deviation 17.7 |
p-value: >0.05t-test, 1 sided