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NCT01811563 · ClinicalTrials.gov registry record · NA
Total Knee Arthroplasty: Functional and Clinical Outcomes
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01811563: Completed NA study, sponsored by Duke University.
NCT01811563 is a NA study that has completed, run by Duke University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01811563, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be
Interventions
- DEVICE Zimmer
- DEVICE Stryker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-02-26 |
| Phase | NA |
What the finished NCT01811563 record still lists
NCT01811563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Zimmer is the first listed.
NCT01811563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01811563 about?
NCT01811563 is a clinical study titled "Total Knee Arthroplasty: Functional and Clinical Outcomes". 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 comp...
What is the current status of trial NCT01811563?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2013-02. Estimated completion is 2016-02-26.
What interventions are being tested in trial NCT01811563?
The interventions under investigation include: Zimmer (DEVICE), Stryker (DEVICE).
Who is sponsoring clinical trial NCT01811563?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01811563's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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