Recruiting

ORIF vs. DFR

Sponsor:

University of Florida

Code:

NCT05792189

Conditions

Distal Femur Fracture

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Koos Jr assesment on subjects with ORIF of distal femur fractures

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

Koos Jr assesment on subjects with DFR of distal femur fracture

Study Details

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)

Conditions

Distal Femur Fracture

Study ID

NCT05792189

Start date

Apr 12, 2023

Status verified date

Aug, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

active comparator: Distal femur replacement total knee arthroplasty (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

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Open reduction and internal fixation (ORIF) of distal femur fracture [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Matthew Patrick, MD

352-273-7188patrimr@ortho.ufl.edu

Dykes Viginia, DAT

352-273-7343jacksve@ortho.ufl.edu

Locations

UF & Shands Orthopaedics and Sports Medicine Institute

Recruiting

Gainesville, Florida, United States, 32607

More Information

Sponsor

University of Florida

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-14.