In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA

Study Purpose

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].

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.

- Subjects must be at least six months post-operative.

- Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.

- Participants must be able to perform the required activities - stepping up and a deep knee bend.

- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.

Exclusion Criteria:

- 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.

- Subjects without one of the two types of knee implants under investigation.

- Subjects who are unable to perform stepping up and deep knee bend.

- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.

- Does not speak English.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04103502
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Tennessee, Knoxville
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Richard Komistek, Ph.D.
Principal Investigator Affiliation	The University of Tennessee
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Total Knee Arthroplasty, Osteo Arthritis Knee, Knee Injuries, Knee Imlant

Additional Details

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.

Arms & Interventions

Arms

: MicroPort Medial Pivot

Subjects will have been implanted with the MicroPort Medial Pivot TKA

: DePuy Attune

Subjects will have been implanted with the DePuy Attune PCR TKA

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nevada Orthopedic & Spine Center, Las Vegas, Nevada

Status

Address

Nevada Orthopedic & Spine Center

Las Vegas, Nevada, 89128

Site Contact

Russell Nevins, MD

[email protected]

702-258-3773

Platinum Training/MERIN, Las Vegas, Nevada

Status

Address