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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Total knee replacement with NexGen CR knee prosthesis; Device: Total knee replacement(TKR) with Nexgen CR-flex

• Registration Number: NCT00837447
• Lead Sponsor: Ewha Womans University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Results First Submitted: 2011-06-23
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Results First Posted: 2013-04-10
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NexGen CR knee prosthesis	Total knee replacement with NexGen CR knee prosthesis	side of knee operated with total knee replacement with Nexgen CR prosthesis
NexGen CR-Flex knee prosthesis	Total knee replacement(TKR) with Nexgen CR-flex	side of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis

Primary Outcome Measures

Name	Time	Method
Change in Knee Society Knee Score	baseline and 3 years	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