In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA) (TKA)

In Vivo Kinematics for Subjects Implanted With Klassic TKA

In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee; Knee Injuries; Total Knee Arthroplasty; Knee Implant
• Intervention / Treatment: Device: Klassic Knee System

Detailed Description

Enrollment will be increased to 24 subjects 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. At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Hofmann Arthritis Institute for Precision Joint Replacement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of Dr. Aaron Hofmann who have been implanted with the Klassic Knee System

Description

Inclusion Criteria:

1. Subjects will have a Klassic knee system.
2. Subjects must be at least six months post-operative.
3. Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than 80.
4. Participants must be able to perform a deep knee bend.
5. Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
6. Must speak English.

Exclusion Criteria:

1. 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.
2. Subjects without the required type of knee implant.
3. Bilateral subjects (i.e., patients with both knees implanted)
4. Subjects who are unable to perform a deep knee bend.
5. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
6. Subjects who do not speak English

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Klassic TKA; Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.	Device: Klassic Knee System; At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Rotation (AR) During Deep Knee Bend	Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.	at least 6 months post-operative
Maximum Weight-bearing Flexion During Deep Knee Bend	Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.	at least 6 months post-operative
Medial Condyle Translations During Deep Knee Bend Activity.	Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.	at least 6 months post-operative
Lateral Condyle Translations During Deep Knee Bend Activity	Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.	at least 6 months post-operative

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: Duke University; Hofmann Arthritis Institute
• Investigators: Principal Investigator: Richard Komistek, Ph.D., The University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; total knee arthroplasty; knee implant
• 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: WIRB20182087

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 by the secure server after data are uploaded.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No