Total Knee Arthroplasty: Functional and Clinical Outcomes



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 85
Updated:12/21/2016
Start Date:February 2013
End Date:February 2016

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Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants

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.


Inclusion Criteria:

1. Patients requiring primary total knee replacement

2. Patients willing and able to comply with the follow-up visits and evaluations

3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

1. Patients with inflammatory arthritis

2. Patients with diabetic neuropathy

3. Patients unable to ambulate without the use of an assistive device prior to surgery

4. Patients unable to stand in single limb stance on each foot prior to surgery.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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