Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hofmann Arthritis Institute | UNKNOWN |
| Duke University | OTHER |
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Klassic Knee System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients of Dr. Aaron Hofmann who have been implanted with the Klassic Knee System
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Komistek, Ph.D. | The University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hofmann Arthritis Institute for Precision Joint Replacement | Salt Lake City | Utah | 84102 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | degrees | at least 6 months post-operative |
|
at least 6 months post-operative
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Komistek, Principal Investigator | University of Tennessee | 8659742093 | rkomiste@utk.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2018 | Oct 23, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | 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. | Posted | Mean | Standard Deviation | mm | 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. | Posted | Mean | Standard Deviation | mm | at least 6 months post-operative |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
Not provided
Not provided
| D009140 |
| Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |