The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Study Overview
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Brief Summary
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Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.

Detailed Description
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This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.

Official Title
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The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: the gap balance type of total knee arthroplasty
* Procedure: the measured resection type of total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications Exclusion Criteria: There are surgical contraindications Varus or valgus alignment exceeds 20 degrees

Ages Eligible for Study
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Minimum Age: 65 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: gap balance group<br>The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed. | Procedure: the gap balance type of total knee arthroplasty<br>* A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.<br>|
| Active Comparator: measured resection group<br>The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed. | Procedure: the measured resection type of total knee arthroplasty<br>* A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| femoral component rotation | The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint. | 6 weeks after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, CT scan