Clinical trial NCT04113785: In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)
Official title: In Vivo Kinematics for Subjects Implanted With Klassic TKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Osteo Arthritis Knee
Knee Implant
Knee Injuries
Keywords: total knee arthroplasty
knee implant
osteoarthritis
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Hofmann Arthritis Institute
name: Duke University
First posted: 2019-10-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Dr. Aaron Hofmann who have been implanted with the Klassic Knee System

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.

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

Eligibility 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

Primary outcomes:
measure: Axial Rotation (AR) During Deep Knee Bend
timeFrame: at least 6 months post-operative
measure: Maximum Weight-bearing Flexion During Deep Knee Bend
timeFrame: at least 6 months post-operative
measure: Medial Condyle Translations During Deep Knee Bend Activity.
timeFrame: at least 6 months post-operative
measure: Lateral Condyle Translations During Deep Knee Bend Activity
timeFrame: at least 6 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Hofmann Arthritis Institute for Precision Joint Replacement
state: Utah
Study officials:
affiliation: The University of Tennessee
name: Richard Komistek, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: