- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792189
Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)
July 7, 2023 updated by: University of Florida
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
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Patrick, MD
- Phone Number: 352-273-7188
- Email: patrimr@ortho.ufl.edu
Study Contact Backup
- Name: Marissa Pazik, MS
- Phone Number: 352-273-7359
- Email: pazikmn@ortho.ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32607
- Recruiting
- UF & Shands Orthopaedics and Sports Medicine Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
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.
|
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2023
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Study Registration Dates
First Submitted
February 28, 2023
First Submitted That Met QC Criteria
March 29, 2023
First Posted (Actual)
March 31, 2023
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202300246
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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