Trials / Terminated
TerminatedNCT02228538
Total Knee Arthroplasty Functional Outcomes Study Research Design
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- Restor3D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.
Detailed description
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total knee arthroplasty patients | ConforMIS iTotal (CR) knee implant system \& off-the-shelf standard knee implant system from various manufacturers |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-05-01
- Completion
- 2016-09-01
- First posted
- 2014-08-29
- Last updated
- 2023-10-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02228538. Inclusion in this directory is not an endorsement.