An observational study in Osteoarthritis, Knee and Joint Disease, sponsored by Medacta International SA. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Medacta International SA · Observational
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.
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.
Exclusion Criteria:
Patients enrolled prospectively with surgeries planned to get kinematic alignment
Procedure: Kinematic alignment · Device: GMK Sphere®
Historical group who had mechanical alignment, match-paired with the prospective group
Procedure: Mechanical alignment · Device: GMK Sphere®
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.
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
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.
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)
Time frame: 1-year follow-up
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"
Time frame: 1-year follow-up
Residual deformity
The residual deformity is evaluated by long axis Xray analysis: HKA angle
Time frame: 1-year follow-up
Flexion-extension contracture
The flexion-extension contracture is evaluated by a subscore of the new KSS: "Joint motion"
Time frame: 1-year follow-up
Self-reported pain, function and stiffness
These aspects are evaluated through KOOS score
Time frame: 1-year follow-up
Ability to forget about artificial joint
Through the use of the Forgotten Joint Score
Time frame: 1-year follow-up
Plan to share: Undecided
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Medacta International SA