Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

Study Overview
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Brief Summary
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A prospective study will be performed to compare the clinical outcome after total knee arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an intramedullary system. The extramedullary femoral alignment system is newly designed. These two systems are used to make the distal femoral resection in 100 patients in a random order.

Official Title
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A Comparative Study of Femoral Extramedullary and Intramedullary Alignment Systems in Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Distal femoral resection in total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Varus knee; degrees of extra articular deformity < 15°; Knee Osteoarthritis; Straight limited < 30°; range of knee flexion > 90°; No hip abnormalities Exclusion Criteria: Valgus knee; degrees of extra articular deformity > 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male Extramedullary<br>In this group, patients are male and femoral extramedullary resection would be used. | Procedure: Distal femoral resection in total knee arthroplasty<br>* EM and IM alignment systems are used to make the distal femoral cut in a random order.<br>|
| Experimental: Female Extramedullary<br>In this group, patients are female and femoral extramedullary resection would be used. | Procedure: Distal femoral resection in total knee arthroplasty<br>* EM and IM alignment systems are used to make the distal femoral cut in a random order.<br>|
| Active Comparator: Male Intramedullary<br>In this group, patients are male and femoral Intramedullary resection would be used. | Procedure: Distal femoral resection in total knee arthroplasty<br>* EM and IM alignment systems are used to make the distal femoral cut in a random order.<br>|
| Active Comparator: Female Intramedullary<br>In this group, patients are female and femoral Intramedullary resection would be used. | Procedure: Distal femoral resection in total knee arthroplasty<br>* EM and IM alignment systems are used to make the distal femoral cut in a random order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging tests | Evaluate the X-ray changes. Measuring the hip-knee-ankle (HKA) angle by x-ray films | pre surgery and 3, 12 months post surgery | 
| Assess the changes of KSS scores | KSS scores will be recorded. | pre surgery and 3, 12 months post surgery | 
| Assess the changes of SF-36 scores | SF-36 scores will be recorded | pre surgery and 3, 12 months post surgery | 
| Assess the changes of WOMAC scores | WOMAC scores will be recorded. | pre surgery and 3, 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| deep vein thrombosis (DVT) | DVT was diagnosed by 3 experienced radiologists 96 according to Robinov group's criterion. | pre surgery and 3, 12 months post surgery | 
| Range of knee motion | Range of knee motion will be recorded. | pre surgery and 3, 12 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extramedullary, intramedullary, total knee arthroplasty (TKA)