Knee Implant, Knee Injuries, Osteo Arthritis Knee, Total Knee Arthroplasty
Conditions
Keywords
total knee arthroplasty, knee implant, osteoarthritis
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
Interventions
DEVICEKlassic 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
Sponsors
Hofmann Arthritis Institute
Duke University
The University of Tennessee, Knoxville
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Rotation (AR) During Deep Knee Bend | 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. |
| Maximum Weight-bearing Flexion During Deep Knee Bend | 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. |
| Medial Condyle Translations During Deep Knee Bend Activity. | 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. |
| Lateral Condyle Translations During Deep Knee Bend Activity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Klassic TKA |
|---|---|
| Age, Categorical <=18 years | NA Participants |
| Age, Categorical >=65 years | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants |
| Race (NIH/OMB) Asian | NA Participants |
| Race (NIH/OMB) Black or African American | NA Participants |
| Race (NIH/OMB) More than one race | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants |
| Race (NIH/OMB) White | NA Participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: at least 6 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Klassic TKA | Axial Rotation (AR) During Deep Knee Bend | 6.6 degrees | Standard Deviation 3.2 |
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.
Time frame: at least 6 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Klassic TKA | Lateral Condyle Translations During Deep Knee Bend Activity | 2.5 mm | Standard Deviation 2 |
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.
Time frame: at least 6 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Klassic TKA | Maximum Weight-bearing Flexion During Deep Knee Bend | 111.7 degrees | Standard Deviation 13.3 |
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.
Time frame: at least 6 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Klassic TKA | Medial Condyle Translations During Deep Knee Bend Activity. | 2.5 mm | Standard Deviation 2 |