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

NCT04103502 | Withdrawn FDA Device

• 1 other identifier: WIRB20181868
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Kinematics Translations during Deep Knee Bend Activity

  Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend

  at least 6 months post-operative

• Kinematics during Deep Knee Bend Activity

  Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB

  at least 6 months post-operative

• Kinematics Translations during step up activity

  Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity

  at least 6 months post-operative

• Kinematics during step up activity

  Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity

  at least 6 months post-operative

Study Arms (2)

MicroPort Medial Pivot

Subjects will have been implanted with the MicroPort Medial Pivot TKA

Device: MicroPort Medial Pivot TKA

DePuy Attune

Subjects will have been implanted with the DePuy Attune PCR TKA

Device: DePuy Attune PCR TKA

Interventions

MicroPort Medial Pivot TKA DEVICE

Subjects will have been implanted with the MicroPort Medial Pivot TKA

MicroPort Medial Pivot

DePuy Attune PCR TKA DEVICE

Subjects will have been implanted with the DePuy Attune PCR TKA

DePuy Attune

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• MicroPort Orthopedics Inc.: collaborator

Study Sites (3)

Nevada Orthopedic & Spine Center

Las Vegas, Nevada, 89128, United States

Location

Platinum Training/MERIN

Las Vegas, Nevada, 89130, United States

Location

The University of Tennessee

Knoxville, Tennessee, 37934, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Richard Komistek, Ph.D.

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: May 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: May 5, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)