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

Closed Supracondylar Fracture of Femur Clinical Trial

— WtBrFemFx  

Official title:

Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167099
• Other study ID #: 1408401969A
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 2018

Study information

• Verified date: June 2022
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Closed Supracondylar Fracture of Femur
• Femoral Fractures
• Fractures, Bone

Intervention

Procedure:
• Full Weight Bearing
full weight bearing after fixation of a distal femur fracture

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Days to Discharge	Investigators record the number of days from surgery to discharge	Up to 30 days
Other	Discharge Disposition	Investigators record the participants' discharge location, e.g. home, rehabilitation facility	Up to 30 days
Other	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
Other	Change in Knee Society Score	Participants complete the Knee Society survey at the listed time points	6 weeks, 3 months, 6 months, 12 months
Other	Knee Flexion	Investigators measure knee flexion	12 months
Other	Number of Participants With Non Union	Investigators assess non union at 1 year	12 months
Other	Number of Participants With Malunion	Investigators assess malunion at 1 year	12 months
Other	Number of Participants With Infection	Investigators check for infection	12 months
Other	Deep Vein Thrombosis at Each Time Point	Investigators check for Deep Vein Thrombosis	12 months
Other	Number of Participants With Pulmonary Embolism	Investigators check for Pulmonary Embolism	12 months
Other	Number of Participants With Implant Failure	Investigators check for implant failure at 12 months	12 months
Other	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
Other	Study Mortality	Investigators record any deaths at 12 months	12 months
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.	up to 12 weeks
Secondary	Time to Ambulation	Investigators measure time to ambulation	up to 24 weeks
Secondary	Time of Participation in Physical Therapy	Investigators measure the length of time of physical therapy participation	up to 1 year