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The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.
The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinematic alignment with GMK Sphere® | Patients enrolled prospectively with surgeries planned to get kinematic alignment |
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| Mechanical alignment with GMK Sphere® | Historical group who had mechanical alignment, match-paired with the prospective group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinematic alignment | Procedure | The principle for kinematically aligning the femoral component is to remove the correct amount of bone and cartilage from the distal and posterior femur after accounting for wear and saw blade kerf, so that the total thickness of the missing and removed tissue matches the thickness of the femoral component. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score | The new KSS (from the publication of 2011, Giles R. Scuderi MD "The New Knee Society Knee Scoring System" Clin Orthop Relat Res (2012) 470:3-19) includes a part filled by the surgeon and one by the patient. The first outcome is focused on the "Functional Activities" subscore, excluding the "Discretionary knee activities". The maximum is 85 points while the minimum is -10 points. The "Functional Activities" score includes 3 subscores: WALKING AND STANDING (min -10, max 30), STANDARD ACTIVITIES (min 0, max 30) and ADVANCED ACTIVITIES (min 0, max 25) | 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional improvement, satisfaction and symptoms | The functional improvement, satisfaction and symptoms is the sum of the following subscores of the new KSS: "Functional Activities", "Patient Satisfaction" and "Symptoms" | 1-year follow-up |
| Residual deformity |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited during the preoperative visit at the investigational site. All patients scheduled for a total knee replacements, meeting the inclusion criteria and none of the exclusion criteria will be invited to the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vinzenz Krankenhaus Brakel | Brakel | North Rhine-Westphalia | 33034 | Germany |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Mechanical alignment | Procedure | Classic mechanical alignment (MA) in total knee arthroplasty (TKA) is meant to co-align the prosthetic components to the mechanical axes of the femur and tibia and restore neutral overall limb alignment |
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| GMK Sphere® | Device | The GMK Sphere® is a total knee prosthesis . The design of the GMK Sphere® is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial UHMWPE polyethylene insert with a concave spherical medial compartment. |
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The residual deformity is evaluated by long axis Xray analysis: HKA angle |
| 1-year follow-up |
| Flexion-extension contracture | The flexion-extension contracture is evaluated by a subscore of the new KSS: "Joint motion" | 1-year follow-up |
| Self-reported pain, function and stiffness | These aspects are evaluated through KOOS score | 1-year follow-up |
| Ability to forget about artificial joint | Through the use of the Forgotten Joint Score | 1-year follow-up |