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

NCT04113785 | Completed Results FDA Device

• 1 other identifier: WIRB20182087
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty; Osteo Arthritis Knee; Knee Implant; Knee Injuries

Keywords

total knee arthroplasty; knee implant; osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Klassic Knee System DEVICE

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

Klassic TKA

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

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

You may qualify if:

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

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 the required type of knee implant.
• Bilateral subjects (i.e., patients with both knees implanted)
• Subjects who are unable to perform a deep knee bend.
• Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
• Subjects who do not speak English

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Hofmann Arthritis Institute: collaborator
• Duke University: collaborator

Study Sites (1)

Hofmann Arthritis Institute for Precision Joint Replacement

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Conditions

Knee Injuries; Osteoarthritis

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Richard Komistek, Principal Investigator
• Organization: University of Tennessee

rkomiste@utk.edu

8659742093

Study Officials

• Richard Komistek, Ph.D.

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: June 5, 2019
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)