Periprosthetic Distal Femur Fracture

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periprosthetic Fractures; Distal Femur Fractures
• Intervention / Treatment: Procedure: Locked Compression Plating; Procedure: Retrograde Intramedullary Nailing (RIMN)

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1R6
      • Recruiting
      • St. Michael's Hospital, Department of Orthopaedic Surgery
      • Sub-Investigator: Emil Schemitsch, MD, FRCAC
      • Principal Investigator: Aaron Nauth, MD, FRCSC
      • Sub-Investigator: Michael McKee, MD, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Locked Compression Plating; A direct lateral approach to the distal femur will be employed utilizing minimally invasive and indirect reduction techniques. After fracture reduction is achieved with the use of intra-operative fluoroscopy, a locking plate will be provisionally implanted. Following confirmation of placement, definitive fixation will follow with multiple locking screws in the distal fragment and bicortical screw fixation proximally. A standard layered closure will follow	Procedure: Locked Compression Plating
EXPERIMENTAL: Retrograde Intramedullary Nailing (RIMN); The previous midline knee incision will be employed to access to the knee joint, allowing exposure of the femoral start point via the open box in the femoral component. Following reaming of the canal, an appropriately sized retrograde nail will be inserted. Intra-operative fluoroscopy will be used to confirm reduction. Both proximal and distal locking screws will be used to transfix the nail. A standard layered closure will follow.	Procedure: Retrograde Intramedullary Nailing (RIMN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Rates of re-operation	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Rates of malunion	12 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Emil Schemitsch, MD, FRCSC, Unity Health Toronto

Publications and helpful links

General Publications

• Claireaux HA, Searle HK, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (ESTIMATE): October 31, 2013

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Periprosthetic Fractures
• Other Study ID Numbers: PPDF