Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures (WtBrFemFx)

West Virginia University

Status: Completed

Conditions: Closed Supracondylar Fracture of Femur

Treatments: Procedure: Full Weight Bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT03167099

1408401969A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Full Weight Bearing

Experimental group

Description:

Participants assigned to full weight bearing after fixation of distal femur fracture.

Treatment:

Procedure: Full Weight Bearing

Partial Weight Bearing

No Intervention group

Description:

Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.