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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Patrick, MD | Contact | 352-273-7188 | patrimr@ortho.ufl.edu | |
| Dykes Viginia, DAT | Contact | 352-273-7343 | jacksve@ortho.ufl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF & Shands Orthopaedics and Sports Medicine Institute | Recruiting | Gainesville | Florida | 32607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17403800 | Background | 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. | |
| 30180053 | 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. |
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Prospective, non randomized study
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| 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. |
|
| Up to 2 years |
| 27449717 | 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. |
| 34001801 | 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. |
| 31924488 | 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. |
| ID | Term |
|---|---|
| D000092524 | Femoral Fractures, Distal |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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