Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)

University of Florida

Status: Enrolling

Conditions: Distal Femur Fracture

Treatments: Other: Koos Jr assesment on subjects with DFR of distal femur fracture; Other: Timed Up and Go Test on subjects with DFR of distal femur fracture; Other: Timed Up and Go Test on subjects with ORIF of distal femur fractures; Other: Koos Jr assesment on subjects with ORIF of distal femur fractures

Study type: Interventional

Funder types: Other

Identifiers

NCT05792189

IRB202300246

Details and patient eligibility

About

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)

Full description

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). Several small retrospective studies have compared outcomes with mixed results. To the authors' knowledge there are no prospective studies evaluating the outcomes after treatment of periprosthetic distal femur fractures. The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score).

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking patients
• 55 years or older with Su Type II or Su Type III periprosthetic femur fractures or OTA/OA 33C or 338/3 native knee distal femur fracturing requiring surgical intervention and are medically fit to undergo surgical intervention

Exclusion criteria

• Patients with an active total knee prosthetic infection
• Patients unable to undergo surgical intervention
• Patient with an open fracture
• Non-English-speaking patients
• Oncologic/pathologic fracture
• Poly-trauma patient (or other associated major orthopaedic injuries)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Open reduction and internal fixation (ORIF) of distal femur fracture

Active Comparator group

Description:

Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years

Treatment:

Other: Koos Jr assesment on subjects with ORIF of distal femur fractures

Other: Timed Up and Go Test on subjects with ORIF of distal femur fractures

Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture

Active Comparator group

Description:

Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years

Treatment:

Other: Timed Up and Go Test on subjects with DFR of distal femur fracture

Other: Koos Jr assesment on subjects with DFR of distal femur fracture