Periprosthetic Distal Femur Fracture

Periprosthetic Fractures Clinical Trial

Official title:

Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973712
• Other study ID #: PPDF
• Status: Recruiting
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2022

Study information

• Verified date: June 2021
• Source: Unity Health Toronto
• Contact: Milena Vicente, RN, CCRP
• Phone: 416-864-6060
• Email: vicentem[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.

Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.

The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent

EXCLUSION CRITERIA:

Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) > 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up

Related Conditions & MeSH terms

• Distal Femur Fractures
• Femoral Fractures
• Fractures, Bone
• Periprosthetic Fractures

Intervention

Procedure:
• Locked Compression Plating

• Retrograde Intramedullary Nailing (RIMN)

Locations

Country	Name	City	State
Canada	St. Michael's Hospital, Department of Orthopaedic Surgery	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of malunion		12 months
Primary	Timed Up and Go (TUG) test	The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again	3 months
Secondary	Rates of re-operation		12 months