Distal Femur Fractures, Periprosthetic Fractures
Conditions
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.
Interventions
PROCEDURELocked Compression Plating
PROCEDURERetrograde Intramedullary Nailing (RIMN)
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) test | 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
| Measure | Time frame |
|---|---|
| Rates of re-operation | 12 months |
Other
| Measure | Time frame |
|---|---|
| Rates of malunion | 12 months |
Countries
Canada
Contacts
Primary ContactMilena Vicente, RN, CCRP
Outcome results
None listed