Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures

NCT ID: NCT03167099

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-10-31

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.

Conditions

Closed Supracondylar Fracture of Femur

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full Weight Bearing

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

Group Type: EXPERIMENTAL

Full Weight Bearing

Intervention Type: PROCEDURE

full weight bearing after fixation of a distal femur fracture

Partial Weight Bearing

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Full Weight Bearing

full weight bearing after fixation of a distal femur fracture

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

David Hubbard, MD

MD, Chief, Orthopaedic Trauma Service, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David F Hubbard, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1408401969A

Identifier Type: -

Identifier Source: org_study_id