Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses

Study Overview
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Brief Summary
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The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Detailed Description
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The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Official Title
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Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Total knee replacement with NexGen CR knee prosthesis
* Device: Total knee replacement(TKR) with Nexgen CR-flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties Exclusion Criteria: inflammatory arthritis osteoarthritis of the hip causing pain or restricted mobility a foot or ankle disorder which limited walking dementia or a neurological disorder including a past history of stroke which affected mobility
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 |
| --- | --- |
| Active Comparator: NexGen CR knee prosthesis<br>side of knee operated with total knee replacement with Nexgen CR prosthesis | Device: Total knee replacement with NexGen CR knee prosthesis<br>* comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis<br>* Other names: NexGen CR;|
| Active Comparator: NexGen CR-Flex knee prosthesis<br>side of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis | Device: Total knee replacement(TKR) with Nexgen CR-flex<br>* TKR using Nexgen CR-flex implant<br>* Other names: Nexgen CR-flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Society Knee Score | change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points | baseline and 3 years |