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

The University of Tennessee, Knoxville

Status: Not yet enrolling

Conditions: Knee Injuries; Knee Imlant; Total Knee Arthroplasty; Osteo Arthritis Knee

Treatments: Device: MicroPort Medial Pivot TKA; Device: DePuy Attune PCR TKA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04103502

WIRB20181868

Details and patient eligibility

About

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].

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

24 participants in 2 patient groups

MicroPort Medial Pivot

Description:

Subjects will have been implanted with the MicroPort Medial Pivot TKA

Treatment:

Device: MicroPort Medial Pivot TKA

DePuy Attune

Description:

Subjects will have been implanted with the DePuy Attune PCR TKA

Treatment:

Device: DePuy Attune PCR TKA