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

Primary Purpose

Distal Femur Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fracture

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UF & Shands Orthopaedics and Sports Medicine InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Distal femur replacement total knee arthroplasty (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.

Full Information

First Posted
February 28, 2023
Last Updated
July 7, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05792189
Brief Title
Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
April 1, 2029 (Anticipated)
Study Completion Date
April 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Femur Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, non randomized study
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open reduction and internal fixation (ORIF) of distal femur fracture
Arm Type
Active Comparator
Arm Description
Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years
Arm Title
Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture
Arm Type
Active Comparator
Arm Description
Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years
Intervention Type
Other
Intervention Name(s)
Timed Up and Go Test on subjects with ORIF of distal femur fractures
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Koos Jr assesment on subjects with ORIF of distal femur fractures
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Timed Up and Go Test on subjects with DFR of distal femur fracture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Koos Jr assesment on subjects with DFR of distal femur fracture
Intervention Description
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 Information:
Title
Open reduction and internal fixation (ORIF) of distal femur fracture
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Patrick, MD
Phone
352-273-7188
Email
patrimr@ortho.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Pazik, MS
Phone
352-273-7359
Email
pazikmn@ortho.ufl.edu
Facility Information:
Facility Name
UF & Shands Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
17403800
Citation
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.
Results Reference
background
PubMed Identifier
30180053
Citation
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.
Results Reference
background
PubMed Identifier
27449717
Citation
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.
Results Reference
background
PubMed Identifier
34001801
Citation
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.
Results Reference
background
PubMed Identifier
31924488
Citation
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.
Results Reference
background

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

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