Clinical trial NCT03167099: Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures
Official title: Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Supracondylar Fracture of Femur
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Distal Femur Fracture Healing by Radiographic Evidence
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Time to Ambulation
timeFrame: up to 24 weeks
measure: Time of Participation in Physical Therapy
timeFrame: up to 1 year
Other outcomes:
measure: Number of Days to Discharge
timeFrame: Up to 30 days
measure: Discharge Disposition
timeFrame: Up to 30 days
measure: Change in Pain
timeFrame: 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
measure: Change in Knee Society Score
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Knee Flexion
timeFrame: 12 months
measure: Number of Participants With Non Union
timeFrame: 12 months
measure: Number of Participants With Malunion
timeFrame: 12 months
measure: Number of Participants With Infection
timeFrame: 12 months
measure: Deep Vein Thrombosis at Each Time Point
timeFrame: 12 months
measure: Number of Participants With Pulmonary Embolism
timeFrame: 12 months
measure: Number of Participants With Implant Failure
timeFrame: 12 months
measure: Change in Vit D Level in Age 65 and Older
timeFrame: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
measure: Study Mortality
timeFrame: 12 months
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: David F Hubbard, MD
role: PRINCIPAL_INVESTIGATOR
References: