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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113785
Recruitment Status : Completed
First Posted : October 3, 2019
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Hofmann Arthritis Institute
Duke University
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

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.

Condition or disease Intervention/treatment
Total Knee Arthroplasty Osteo Arthritis Knee Knee Implant Knee Injuries 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

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: In Vivo Kinematics for Subjects Implanted With Klassic TKA
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Axial Rotation (AR) During Deep Knee Bend [ Time Frame: at least 6 months post-operative ]
    Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.

  2. Maximum Weight-bearing Flexion During Deep Knee Bend [ Time Frame: at least 6 months post-operative ]
    Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.

  3. Medial Condyle Translations During Deep Knee Bend Activity. [ Time Frame: at least 6 months post-operative ]
    Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.

  4. Lateral Condyle Translations During Deep Knee Bend Activity [ Time Frame: at least 6 months post-operative ]
    Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Dr. Aaron Hofmann who have been implanted with the Klassic Knee System
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113785


Locations
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United States, Utah
Hofmann Arthritis Institute for Precision Joint Replacement
Salt Lake City, Utah, United States, 84102
Sponsors and Collaborators
The University of Tennessee, Knoxville
Hofmann Arthritis Institute
Duke University
Investigators
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Principal Investigator: Richard Komistek, Ph.D. The University of Tennessee
  Study Documents (Full-Text)

Documents provided by Richard Komistek, The University of Tennessee, Knoxville:

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Responsible Party: Richard Komistek, Principle Investigator, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT04113785    
Other Study ID Numbers: WIRB20182087
First Posted: October 3, 2019    Key Record Dates
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by Richard Komistek, The University of Tennessee, Knoxville:
total knee arthroplasty
knee implant
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Knee Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Leg Injuries
Wounds and Injuries
Rheumatic Diseases