Closed Supracondylar Fracture of Femur
Conditions
Brief summary
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.
Detailed description
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. The hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. Fracture healing will be monitored closely by follow up appointments and complications will be documented.
Interventions
PROCEDUREFull Weight Bearing
full weight bearing after fixation of a distal femur fracture
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Both investigators and participants are aware of the assignment. There is no masking; only randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* aged \> 18 yo * distal supracondylar femur fracture (Supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), including peri-prosthetic fractures) * both male and female
Exclusion criteria
* Patients with an intracondylar split, * polytrauma patients with associated trauma that will inhibit their ability to weight bear, * metastatic disease, * incomplete follow up, * subjects with questionable ability to bear weight (ie advanced dementia), * open fractures with bone loss.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Distal Femur Fracture Healing by Radiographic Evidence | up to 12 weeks | Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | up to 24 weeks | Investigators measure time to ambulation |
| Time of Participation in Physical Therapy | up to 1 year | Investigators measure the length of time of physical therapy participation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Society Score | 6 weeks, 3 months, 6 months, 12 months | Participants complete the Knee Society survey at the listed time points |
| Knee Flexion | 12 months | Investigators measure knee flexion |
| Number of Participants With Non Union | 12 months | Investigators assess non union at 1 year |
| Number of Participants With Malunion | 12 months | Investigators assess malunion at 1 year |
| Number of Participants With Infection | 12 months | Investigators check for infection |
| Number of Days to Discharge | Up to 30 days | Investigators record the number of days from surgery to discharge |
| Number of Participants With Pulmonary Embolism | 12 months | Investigators check for Pulmonary Embolism |
| Number of Participants With Implant Failure | 12 months | Investigators check for implant failure at 12 months |
| Change in Vit D Level in Age 65 and Older | baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months | Investigators assess Vit D level in subject age 65 and older at all time points listed |
| Study Mortality | 12 months | Investigators record any deaths at 12 months |
| Deep Vein Thrombosis at Each Time Point | 12 months | Investigators check for Deep Vein Thrombosis |
| Discharge Disposition | Up to 30 days | Investigators record the participants' discharge location, e.g. home, rehabilitation facility |
| Change in Pain | 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months | Investigators record the pain from 0-10 at each time point |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Weight Bearing Participants assigned to full weight bearing after fixation of distal femur fracture.
Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture. | 26 |
| Partial Weight Bearing Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. | 27 |
| Total | 53 |
Baseline characteristics
| Characteristic | Full Weight Bearing | Partial Weight Bearing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 21 Participants | 43 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 26 | 7 / 27 |
| other Total, other adverse events | 0 / 26 | 1 / 27 |
| serious Total, serious adverse events | 2 / 26 | 2 / 27 |
Outcome results
Primary
Time to Distal Femur Fracture Healing by Radiographic Evidence
Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.
Time frame: up to 12 weeks
Population: Radiographic evidence not available for 4 subjects in each arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Weight Bearing | Time to Distal Femur Fracture Healing by Radiographic Evidence | 1.75 months | Standard Deviation 0.63 |
| Partial Weight Bearing | Time to Distal Femur Fracture Healing by Radiographic Evidence | 2.15 months | Standard Deviation 0.87 |
Secondary
Time of Participation in Physical Therapy
Investigators measure the length of time of physical therapy participation
Time frame: up to 1 year
Population: Data was not collected.
Secondary
Time to Ambulation
Investigators measure time to ambulation
Time frame: up to 24 weeks
Population: Time to ambulation not collected for 7 participants in full weight bearing group; 8 participants in partial weight bearing group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Full Weight Bearing | Time to Ambulation | 9.947 Weeks |
| Partial Weight Bearing | Time to Ambulation | 15.316 Weeks |
Other Pre-specified
Change in Knee Society Score
Participants complete the Knee Society survey at the listed time points
Time frame: 6 weeks, 3 months, 6 months, 12 months
Population: Data not collected.
Other Pre-specified
Change in Pain
Investigators record the pain from 0-10 at each time point
Time frame: 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Population: Data was not collected.
Other Pre-specified
Change in Vit D Level in Age 65 and Older
Investigators assess Vit D level in subject age 65 and older at all time points listed
Time frame: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Population: Data was not collected.
Other Pre-specified
Deep Vein Thrombosis at Each Time Point
Investigators check for Deep Vein Thrombosis
Time frame: 12 months
Population: Data was not collected.
Other Pre-specified
Discharge Disposition
Investigators record the participants' discharge location, e.g. home, rehabilitation facility
Time frame: Up to 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Weight Bearing | Discharge Disposition | Home | 5 Participants |
| Full Weight Bearing | Discharge Disposition | Skilled Nursing Facility | 10 Participants |
| Full Weight Bearing | Discharge Disposition | Acute Rehab | 10 Participants |
| Full Weight Bearing | Discharge Disposition | Hospice/Comfort Measures Only | 1 Participants |
| Partial Weight Bearing | Discharge Disposition | Hospice/Comfort Measures Only | 0 Participants |
| Partial Weight Bearing | Discharge Disposition | Home | 5 Participants |
| Partial Weight Bearing | Discharge Disposition | Acute Rehab | 4 Participants |
| Partial Weight Bearing | Discharge Disposition | Skilled Nursing Facility | 18 Participants |
Other Pre-specified
Knee Flexion
Investigators measure knee flexion
Time frame: 12 months
Population: Knee flexion was not measured in 3 subjects in the full weight bearing group and 5 subjects in the partial weight bearing group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Full Weight Bearing | Knee Flexion | 101 Degrees |
| Partial Weight Bearing | Knee Flexion | 97 Degrees |
Other Pre-specified
Number of Days to Discharge
Investigators record the number of days from surgery to discharge
Time frame: Up to 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Full Weight Bearing | Number of Days to Discharge | 6.115 Days |
| Partial Weight Bearing | Number of Days to Discharge | 6.074 Days |
Other Pre-specified
Number of Participants With Implant Failure
Investigators check for implant failure at 12 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Weight Bearing | Number of Participants With Implant Failure | 2 Participants |
| Partial Weight Bearing | Number of Participants With Implant Failure | 2 Participants |
Other Pre-specified
Number of Participants With Infection
Investigators check for infection
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Weight Bearing | Number of Participants With Infection | 0 Participants |
| Partial Weight Bearing | Number of Participants With Infection | 1 Participants |
Other Pre-specified
Number of Participants With Malunion
Investigators assess malunion at 1 year
Time frame: 12 months
Population: Data was not collected.
Other Pre-specified
Number of Participants With Non Union
Investigators assess non union at 1 year
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Weight Bearing | Number of Participants With Non Union | 0 Participants |
| Partial Weight Bearing | Number of Participants With Non Union | 3 Participants |
Other Pre-specified
Number of Participants With Pulmonary Embolism
Investigators check for Pulmonary Embolism
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Weight Bearing | Number of Participants With Pulmonary Embolism | 0 Participants |
| Partial Weight Bearing | Number of Participants With Pulmonary Embolism | 1 Participants |
Other Pre-specified
Study Mortality
Investigators record any deaths at 12 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Weight Bearing | Study Mortality | 3 Participants |
| Partial Weight Bearing | Study Mortality | 7 Participants |