The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement

Study Overview
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Brief Summary
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The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.

Detailed Description
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A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.

Official Title
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The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Cruciate-retaining (CR) prostheses
* Device: Posterior-stabilized (PS) prostheses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.; Exclusion Criteria: Those who do not meet the inclusion criteria; Neuromuscular dysfunction; Diseases affecting postoperative efficacy evaluation

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients with end-stage knee disease need Total Knee Arthroplasty in both knees. | Device: Cruciate-retaining (CR) prostheses<br>* One leg is conducted TKA with Cruciate-retaining (CR) prostheses.<br>Device: Posterior-stabilized (PS) prostheses<br>* One leg is conducted TKA with Posterior-stabilized (PS) prostheses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSS score changes after TKA | Summed Hospital for special surgery (HSS) score with a maximum score of 100. Higher values represent a better outcome. | 1,3,6,12 months after TKA | 
| KSS score changes after TKA | Summed Knee Society Score (KSS) score with a maximum score of 100. Higher values represent a better outcome. | 1,3,6,12 months after TKA | 
| X-ray evaluation changes after TKA | Evaluation of postoperative X-ray results for lower limb line, prosthesis location and other conditions | 1,3,6,12 months after TKA | 
| Muscle strength measurement changes after TKA | Strength measurement of related muscles according to Lovett muscle strength grading standard. | 1,3,6,12 months after TKA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, CR, PS