Trials / Not Yet Recruiting
Not Yet RecruitingNCT04103502
In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA
In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (estimated)
- Sponsor
- The University of Tennessee, Knoxville · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic \& Spine Center \[this is the location from which participants will be recruited\].
Detailed description
There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MicroPort Medial Pivot TKA | Subjects will have been implanted with the MicroPort Medial Pivot TKA |
| DEVICE | DePuy Attune PCR TKA | Subjects will have been implanted with the DePuy Attune PCR TKA |
Timeline
- Start date
- 2024-05-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2019-09-25
- Last updated
- 2024-05-10
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04103502. Inclusion in this directory is not an endorsement.