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

Total Knee Arthroplasty Clinical Trial

— TKA  

Official title:

In Vivo Kinematics for Subjects Implanted With Klassic TKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113785
• Other study ID #: WIRB20182087
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: October 2019
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 5, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Implant
• Knee Injuries
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
United States	Hofmann Arthritis Institute for Precision Joint Replacement	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Duke University, Hofmann Arthritis Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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