Total Knee Arthroplasty: Functional and Clinical Outcomes
Completed · Not applicable
Conditions studied: Knee Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT01811563
- Run by
- Duke University
- People needed
- 60
- Starts
- 2013-02-01
- Expected to finish
- 2016-02-26
- Last updated by the study team
- 2017-06-02
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients requiring primary total knee replacement
- Patients willing and able to comply with the follow-up visits and evaluations
- Patients willing to sign informed consent approved by the Institutional Review Board
You may not qualify if…
- Patients with inflammatory arthritis
- Patients with diabetic neuropathy
- Patients unable to ambulate without the use of an assistive device prior to surgery
- Patients unable to stand in single limb stance on each foot prior to surgery.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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