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

NCT05792189 | Recruiting

• 1 other identifier: IRB202300246
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Open reduction and internal fixation (ORIF) 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.

  Up to 2 years

Secondary Outcomes (1)

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

  Up to 2 years

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

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.

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

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking patients
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

RECRUITING

Related Publications (5)

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.

  PMID: 30180053 BACKGROUND

• Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open Reduction vs Distal Femoral Replacement Arthroplasty for Comminuted Distal Femur Fractures in the Patients 70 Years and Older. J Arthroplasty. 2017 Jan;32(1):202-206. doi: 10.1016/j.arth.2016.06.006. Epub 2016 Jun 23.

  PMID: 27449717 BACKGROUND

• Wadhwa H, Salazar BP, Goodnough LH, Van Rysselberghe NL, DeBaun MR, Wong HN, Gardner MJ, Bishop JA. Distal Femur Replacement Versus Open Reduction and Internal Fixation for Treatment of Periprosthetic Distal Femur Fractures: A Systematic Review and Meta-Analysis. J Orthop Trauma. 2022 Jan 1;36(1):1-6. doi: 10.1097/BOT.0000000000002141.

  PMID: 34001801 BACKGROUND

• Darrith B, Bohl DD, Karadsheh MS, Sporer SM, Berger RA, Levine BR. Periprosthetic Fractures of the Distal Femur: Is Open Reduction and Internal Fixation or Distal Femoral Replacement Superior? J Arthroplasty. 2020 May;35(5):1402-1406. doi: 10.1016/j.arth.2019.12.033. Epub 2019 Dec 20.

  PMID: 31924488 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Matthew Patrick, MD

CONTACT

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

Dykes Viginia, DAT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, non randomized study

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 31, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)