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NCT Number: NCT05792189

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

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)

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Key information

Conditions

Distal Femur Fracture Femoral Fractures Femoral Fractures, Distal Fractures, Bone Leg Injuries Wounds and Injuries

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

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.

Koos Jr assesment on subjects with ORIF of distal femur fractures

Other

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.

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

Other

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.

Koos Jr assesment on subjects with DFR of distal femur fracture

Other

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dykes Viginia, DAT

CONTACT

[email protected]

352-273-7343

Matthew Patrick, MD

CONTACT

[email protected]

352-273-7188

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Evaluation of the Management of Periprosthetic Distal Femur Fractures and Native Knee Distal Femur Fractures, Comparing Open Reduction Internal Fixation With Distal Femur Replacement, a Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 31, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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