Comparison of Clinical Results of Two Cementless Femoral Stem

Study Overview
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Brief Summary
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In the present study, two types of cementless femoral stem- UTS Stem and UTF-reduced Stem- were utilized in total hip arthroplasty. Due to the design for proximal femur fixation, both femoral stems could prevent stress shielding around the implant, further preventing osteolysis. The difference between both femoral stems is the length, in which UTS Stem is 20% shorter than UTF-reduced Stem. The clinical outcomes of both femoral stems will be compared. Both femoral stems are expected to have equally good radiologic outcome and clinical performance.

Detailed Description
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Total hip arthroplasty (THA) is a common orthopedic procedure aimed at improving joint function and alleviating pain in patients with hip joint degeneration. However, the phenomenon of stress shielding-whereby the mechanical properties of the prosthesis lead to reduced load transmission to the surrounding bone-can compromise long-term outcomes. In particular, uncemented THA designs are susceptible to stress shielding, potentially resulting in bone resorption and implant loosening. To address this challenge, the study focuses on optimizing femoral stem fixation within the proximal femur in two specific stem designs: the UTS and the UTF reduced stem. These stems are strategically designed to enhance load transfer while minimizing stress shielding effects. A total of 60 patients who are undergoing total hip arthroplasty at Linkou Chang Gung Memorial Hospital will be recruited, including 30 patients in the UTS group and 30 patients in the UTF-reduced group.The clinical assessments including Success Rate of prosthesis, Numerical Rating Scale (NRS) for pain, Harris Hip Score (HHS), Medical Outcome Study Short Form-36 (SF-36) and : Dual-energy X-ray absorptiometry (DEXA) scanning for bone mineral density monitoring.

Official Title
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Comparison of Clinical Results of Two Cementless Femoral Stem

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive total hip arthroplasty with either a UTS femoral stem or a UTF-reduced femoral stem after June, 2020 Patients who have not received total hip arthroplasty in the past Exclusion Criteria: Patients who are unable or unwilling to return for follow-up Patients who suffer from mental disorders

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UTS Stem<br>The subjects who received UTS Stem in total hip arthroplasty. | Device: total hip arthroplasty<br>* The indication for total hip arthroplasty is mainly osteoarthritis.<br>|
| UTF-reduced Stem<br>The subjects who received UTF-reduced Stem in total hip arthroplasty. | Device: total hip arthroplasty<br>* The indication for total hip arthroplasty is mainly osteoarthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Failure is defined as removal or revision of any components as a result of mechanical failure or complications. Sucess is defined as implants that are sucessfully implanted without any failure for the duration of 1 year. The success rate will be represented as a percentage (%). | Duration of 1 year | 
| Numerical Rating Scale | Numerical Rating Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain. | Change from baseline at 1 year | 
| Harris Hip Score | Harris Hip Score includes 4 sections that evaluate pain, function, deformity, and range of motion. Total scores is from 0 to 100, higher scores represent a better outcome. | Change from baseline at 1 year | 
| Medical Outcome Study Short Form-36 | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. It consists of two sections, physical component summary and mental component summary, with 36 items in total. | Change from baseline at 1 year | 
| DEXA scanning | DEXA scanning is used to monitor and quantify bone mineral density, which helps to understand if the implant has an effect on the change of bone mineral density. | Change from baseline at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiolucent line | Radiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs. | Change from baseline at 1 year | 
| Valgus/Varus alignment | Radiologic analysis helps measure the degree of the alignment of the hip. | Change from baseline at 1 year | 
| Morphology of the proximal femur | Morphology of the proximal femur was classified using Dorr Type. | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, total hip replacement, femoral stem