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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Weight Bearing | Experimental | Participants assigned to full weight bearing after fixation of distal femur fracture. |
|
| Partial Weight Bearing | No Intervention | Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Weight Bearing | Procedure | full weight bearing after fixation of a distal femur fracture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulation | Investigators measure time to ambulation | up to 24 weeks |
| Time of Participation in Physical Therapy | Investigators measure the length of time of physical therapy participation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days to Discharge | Investigators record the number of days from surgery to discharge | Up to 30 days |
| Discharge Disposition | Investigators record the participants' discharge location, e.g. home, rehabilitation facility |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F Hubbard, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
No individual participant data will be shared with other researchers. Shared group data will be presented at Orthopaedic conferences and through manuscript submission.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Weight Bearing | Participants assigned to full weight bearing after fixation of distal femur fracture. |
| FG001 | Partial Weight Bearing | Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Radiographic evidence not available for 4 subjects in each arm. | Posted | Mean | Standard Deviation | months | up to 12 weeks |
|
1 year from date of surgery
Charts were reviewed at every clinic visit post operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure of Fixation | Product Issues | Systematic Assessment | X-ray shows failure of fixation of right distal femur fracture. Removal of hardware with right distal femoral replacement performance |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD (Chronic Obstructive Pulmonary Disease) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Visit to Emergency Department, complaints of shortness of breath and back pain. Chest x-ray, EKG, and lab work were completed. Clinically stable and discharged home same day. Instructed to follow-up with primary care provider. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Hubbard | West Virginia University | 304-293-3900 | dhubbard@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2019 | May 31, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2019 | May 31, 2022 | ICF_001.pdf |
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Both investigators and participants are aware of the assignment. There is no masking; only randomization.
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| up to 1 year |
| Up to 30 days |
| Change in Pain | Investigators record the pain from 0-10 at each time point | 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months |
| Change in Knee Society Score | Participants complete the Knee Society survey at the listed time points | 6 weeks, 3 months, 6 months, 12 months |
| Knee Flexion | Investigators measure knee flexion | 12 months |
| Number of Participants With Non Union | Investigators assess non union at 1 year | 12 months |
| Number of Participants With Malunion | Investigators assess malunion at 1 year | 12 months |
| Number of Participants With Infection | Investigators check for infection | 12 months |
| Deep Vein Thrombosis at Each Time Point | Investigators check for Deep Vein Thrombosis | 12 months |
| Number of Participants With Pulmonary Embolism | Investigators check for Pulmonary Embolism | 12 months |
| Number of Participants With Implant Failure | Investigators check for implant failure at 12 months | 12 months |
| 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 | baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months |
| Study Mortality | Investigators record any deaths at 12 months | 12 months |
| Partial Weight Bearing |
Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. |
|
|
| Secondary | Time to Ambulation | Investigators measure time to ambulation | Time to ambulation not collected for 7 participants in full weight bearing group; 8 participants in partial weight bearing group | Posted | Mean | Full Range | Weeks | up to 24 weeks |
|
|
|
| Secondary | Time of Participation in Physical Therapy | Investigators measure the length of time of physical therapy participation | Data was not collected. | Posted | up to 1 year |
|
|
| Other Pre-specified | Number of Days to Discharge | Investigators record the number of days from surgery to discharge | Posted | Mean | Full Range | Days | Up to 30 days |
|
|
|
| Other Pre-specified | Discharge Disposition | Investigators record the participants' discharge location, e.g. home, rehabilitation facility | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Other Pre-specified | Change in Pain | Investigators record the pain from 0-10 at each time point | Data was not collected. | Posted | 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months |
|
|
| Other Pre-specified | Change in Knee Society Score | Participants complete the Knee Society survey at the listed time points | Data not collected. | Posted | 6 weeks, 3 months, 6 months, 12 months |
|
|
| Other Pre-specified | Knee Flexion | Investigators measure knee flexion | Knee flexion was not measured in 3 subjects in the full weight bearing group and 5 subjects in the partial weight bearing group. | Posted | Mean | Full Range | Degrees | 12 months |
|
|
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| Other Pre-specified | Number of Participants With Non Union | Investigators assess non union at 1 year | Posted | Count of Participants | Participants | 12 months |
|
|
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| Other Pre-specified | Number of Participants With Malunion | Investigators assess malunion at 1 year | Data was not collected. | Posted | 12 months |
|
|
| Other Pre-specified | Number of Participants With Infection | Investigators check for infection | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Deep Vein Thrombosis at Each Time Point | Investigators check for Deep Vein Thrombosis | Data was not collected. | Posted | 12 months |
|
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| Other Pre-specified | Number of Participants With Pulmonary Embolism | Investigators check for Pulmonary Embolism | Posted | Count of Participants | Participants | 12 months |
|
|
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| Other Pre-specified | Number of Participants With Implant Failure | Investigators check for implant failure at 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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 | Data was not collected. | Posted | baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months |
|
|
| Other Pre-specified | Study Mortality | Investigators record any deaths at 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 3 |
| 26 |
| 2 |
| 26 |
| 0 |
| 26 |
| EG001 | Partial Weight Bearing | Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. | 7 | 27 | 2 | 27 | 1 | 27 |
|
| Fracture from fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fell day after discharge following initial femur repair, fracturing other side. ORIF (open reduction and internal fixation) to other femur performed. |
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| Nonunion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Evidence of left distal femoral nonunion. Revision performed 11 months postoperatively. |
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| Fall unknown source | Musculoskeletal and connective tissue disorders | Systematic Assessment | Left periprosthetic proximal femur fracture, open exam under anesthesia performed. |
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| Acute Rehab |
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| Hospice/Comfort Measures Only |
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