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

Summary

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)

Conditions

• Distal Femur Fracture

Interventions

OTHER

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

Subjects will perform the Timed Up and Go Test This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair. Test will be performed at 6 weeks, 3 months, 6 months, 12 months and 24 months post surgical treatment.

OTHER

Koos Jr assesment on subjects with ORIF of distal femur fractures

Subjects will complete the KOOS Jr assessment. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

OTHER

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

Subjects will perform the Timed Up and Go Test This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair. Test will be performed at 6 weeks, 3 months, 6 months, 12 months and 24 months post surgical treatment.

OTHER

Koos Jr assesment on subjects with DFR of distal femur fracture

Subjects will complete the KOOS Jr assessment. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

Sponsors & Collaborators

• University of Florida

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-12

Primary Completion

2029-04-01

Completion

2029-04-01

Countries

• United States

Study Locations