Periprosthetic Distal Femur Fracture

• ClinicalTrials.gov Identifier: NCT01973712
• Recruitment Status: Recruiting
• First Posted: October 31, 2013
• Last Update Posted: June 18, 2021
• Sponsor: Unity Health Toronto
• Information provided by (Responsible Party): Unity Health Toronto

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Periprosthetic Fractures; Distal Femur Fractures	Procedure: Locked Compression Plating; Procedure: Retrograde Intramedullary Nailing (RIMN)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
• Study Start Date: May 2014
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Timed Up and Go (TUG) test [ Time Frame: 3 months ]
   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

Secondary Outcome Measures :

1. Rates of re-operation [ Time Frame: 12 months ]

Other Outcome Measures:

1. Rates of malunion [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Milena Vicente, RN, CCRP; 416-864-6060 ext 2608; vicentem@smh.ca

Locations

Canada, Ontario

St. Michael's Hospital, Department of Orthopaedic Surgery; Recruiting

Toronto, Ontario, Canada, M5C 1R6

Contact: Milena Vicente, RN, CCRP 416-864-6060 ext 2608 vicentem@smh.ca

Sub-Investigator: Emil Schemitsch, MD, FRCAC

Principal Investigator: Aaron Nauth, MD, FRCSC

Sub-Investigator: Michael McKee, MD, FRCSC

Sponsors and Collaborators

Unity Health Toronto

Investigators

• Principal Investigator: Aaron Nauth, MD, FRCSC; Unity Health Toronto
• Principal Investigator: Emil Schemitsch, MD, FRCSC; Unity Health Toronto

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT01973712
• Other Study ID Numbers: PPDF
• First Posted: October 31, 2013
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

Additional relevant MeSH terms:

Fractures, Bone; Femoral Fractures; Femoral Fractures, Distal; Periprosthetic Fractures; Wounds and Injuries; Leg Injuries