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A Study to Compare the NexGen CR and CR-Flex Knee Implants

2014-08-27 03:27:21 | BioPortfolio

Summary

The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.

Description

This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Total Knee Arthroplasty

Intervention

NexGen CR-Flex Fixed Bearing Knee, NexGen CR Knee

Location

Dickinson Medical Group, LLC
Milford
Delaware
United States
19963

Status

Active, not recruiting

Source

Zimmer, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:27:21-0400

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Medical and Biotech [MESH] Definitions

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

A region of the lower extremity immediately surrounding and including the KNEE JOINT.

Replacement for a knee joint.

The physical state of supporting an applied load. This often refers to the weight-bearing bones or joints that support the body's weight, especially those in the spine, hip, knee, and foot.

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