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

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

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].

Study Overview

• Status: Not yet recruiting
• Conditions: Osteo Arthritis Knee; Knee Injuries; Total Knee Arthroplasty; Knee Imlant
• Intervention / Treatment: Device: MicroPort Medial Pivot TKA; Device: DePuy Attune PCR TKA

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.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Richard Komistek, Ph.D.; Phone Number: 8659744159; Email: rkomistek@aol.com
• Study Contact Backup: Name: Rebecca Robertson, MLIS; Phone Number: 8659742093; Email: rrober28@utk.edu

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Nevada Orthopedic & Spine Center
      • Contact: Russell Nevins, MD; Phone Number: 702-258-3773
      • Contact: Prisma Limon; Phone Number: (702) 258-3773; Email: prismal@nevadaorthopedic.com
      • Principal Investigator: Russell Nevins, MD
    • Las Vegas, Nevada, United States, 89130
      • Platinum Training/MERIN
      • Contact: Amy Oddo; Phone Number: 702-856-2601; Email: aoddo@platinumtraining.org
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • The University of Tennessee
      • Contact: Richard Komistek, PhD; Phone Number: 865-974-4159; Email: rkomiste@utk.edu
      • Contact: Rebecca Robertson, MLIS; Phone Number: 8659742093; Email: rrober28@utk.edu
      • Principal Investigator: Richard Komistek, PhD
      • Sub-Investigator: Adrija Sharma, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MicroPort Medial Pivot; Subjects will have been implanted with the MicroPort Medial Pivot TKA	Device: MicroPort Medial Pivot TKA; Subjects will have been implanted with the MicroPort Medial Pivot TKA
DePuy Attune; Subjects will have been implanted with the DePuy Attune PCR TKA	Device: DePuy Attune PCR TKA; Subjects will have been implanted with the DePuy Attune PCR TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Richard Komistek, Ph.D., The University of Tennessee

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries
• Other Study ID Numbers: WIRB20181868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes