Clinical trial NCT04103502: In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA
Official title: In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Total Knee Arthroplasty
Osteo Arthritis Knee
Knee Injuries
Knee Imlant
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
First posted: 2019-09-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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 \[this is the location from which participants will be recruited\].

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.

Eligibility 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.

Primary outcomes:
measure: Kinematics Translations during Deep Knee Bend Activity
timeFrame: at least 6 months post-operative
measure: Kinematics during Deep Knee Bend Activity
timeFrame: at least 6 months post-operative
measure: Kinematics Translations during step up activity
timeFrame: at least 6 months post-operative
measure: Kinematics during step up activity
timeFrame: at least 6 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Nevada Orthopedic & Spine Center
state: Nevada
city: Las Vegas
country: United States
facility: Platinum Training/MERIN
state: Nevada
city: Knoxville
country: United States
facility: The University of Tennessee
state: Tennessee
Study officials:
affiliation: The University of Tennessee
name: Richard Komistek, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: