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

Total Knee Arthroplasty Clinical Trial

— TKA PCR  

Official title:

In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04103502
• Other study ID #: WIRB20181868
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: The University of Tennessee, Knoxville
• Contact: Richard Komistek, Ph.D.
• Phone: 8659744159
• Email: rkomistek[@]aol.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Imlant
• Knee Injuries
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Device:
• MicroPort Medial Pivot TKA
Subjects will have been implanted with the MicroPort Medial Pivot TKA
• DePuy Attune PCR TKA
Subjects will have been implanted with the DePuy Attune PCR TKA

Locations

Country	Name	City	State
United States	The University of Tennessee	Knoxville	Tennessee
United States	Nevada Orthopedic & Spine Center	Las Vegas	Nevada
United States	Platinum Training/MERIN	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematics Translations during Deep Knee Bend Activity	Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend	at least 6 months post-operative
Primary	Kinematics during Deep Knee Bend Activity	Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB	at least 6 months post-operative
Primary	Kinematics Translations during step up activity	Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity	at least 6 months post-operative
Primary	Kinematics during step up activity	Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity	at least 6 months post-operative