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

Not Applicable

Recruiting

• Conditions: Distal Femur Fracture
• Interventions: Other: Timed Up and Go Test on subjects with ORIF of distal femur fractures; Other: Timed Up and Go Test on subjects with DFR of distal femur fracture; Other: Koos Jr assesment on subjects with ORIF of distal femur fractures; Other: Koos Jr assesment on subjects with DFR of distal femur fracture

• Registration Number: NCT05792189
• Lead Sponsor: University of Florida

Brief 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)

Detailed 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).

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-03-31
• Study Start: 2023-04-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2029-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• English speaking patients
• 55 years or older with Su Type II or Su Type II periprosthetic femur fractures 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open reduction and internal fixation (ORIF) of distal femur fracture	Koos Jr assesment on subjects with ORIF of distal femur fractures	Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years
Open reduction and internal fixation (ORIF) of distal femur fracture	Timed Up and Go Test on subjects with ORIF of distal femur fractures	Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years
Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture	Timed Up and Go Test on subjects with DFR of distal femur fracture	Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years
Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture	Koos Jr assesment on subjects with DFR of distal femur fracture	Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years

Primary Outcome Measures

Name	Time	Method
Open reduction and internal fixation (ORIF) of distal femur fracture	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture	Up to 2 years	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.

Trial Locations

Locations (1)

UF & Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States