N/A
N=21
In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)
Total Knee Arthroplasty · Osteo Arthritis Knee · Knee Implant · Knee Injuries
Bottom Line
View on ClinicalTrials.gov: NCT04113785 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Axial Rotation (AR) During Deep Knee Bend — 6.6 degrees
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Klassic Knee System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Axial Rotation (AR) During Deep Knee Bend |
6.6 | — |
| PRIMARY Maximum Weight-bearing Flexion During Deep Knee Bend |
111.7 | — |
| PRIMARY Medial Condyle Translations During Deep Knee Bend Activity. |
2.5 | — |
| PRIMARY Lateral Condyle Translations During Deep Knee Bend Activity |
2.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04113785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.