TKA PCR: In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA
Study Details
Study Description
Brief 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].
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MicroPort Medial Pivot Subjects will have been implanted with the MicroPort Medial Pivot TKA |
Device: MicroPort Medial Pivot TKA
Subjects will have been implanted with the MicroPort Medial Pivot TKA
|
| DePuy Attune Subjects will have been implanted with the DePuy Attune PCR TKA |
Device: DePuy Attune PCR TKA
Subjects will have been implanted with the DePuy Attune PCR TKA
|
Outcome Measures
Primary Outcome Measures
- Kinematics Translations during Deep Knee Bend Activity [at least 6 months post-operative]
Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend
- Kinematics during Deep Knee Bend Activity [at least 6 months post-operative]
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
- Kinematics Translations during step up activity [at least 6 months post-operative]
Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity
- Kinematics during step up activity [at least 6 months post-operative]
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.
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Subjects must be at least six months post-operative.
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Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.
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Participants must be able to perform the required activities - stepping up and a deep knee bend.
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Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study
Exclusion Criteria:
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Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
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Subjects without one of the two types of knee implants under investigation.
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Subjects who are unable to perform stepping up and deep knee bend.
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Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
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Does not speak English.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nevada Orthopedic & Spine Center | Las Vegas | Nevada | United States | 89128 |
| 2 | Platinum Training/MERIN | Las Vegas | Nevada | United States | 89130 |
| 3 | The University of Tennessee | Knoxville | Tennessee | United States | 37934 |
Sponsors and Collaborators
- The University of Tennessee, Knoxville
- MicroPort Orthopedics Inc.
Investigators
- Principal Investigator: Richard Komistek, Ph.D., The University of Tennessee
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WIRB20181868