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Total Knee Arthroplasty: Functional and Clinical Outcomes

NCT01811563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-02

Study results available
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Summary

The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

Conditions

Interventions

DEVICE

Zimmer

DEVICE

Stryker

Sponsors & Collaborators

Principal Investigators

  • Samuel S Wellman, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-02-26
Completion
2016-02-26

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01811563 on ClinicalTrials.gov