Matched Pair Study - Kinematic Vs Mechanical Alignment
- Conditions
- Osteoarthritis, KneeJoint Disease
- Interventions
- Procedure: Kinematic alignmentProcedure: Mechanical alignmentDevice: GMK Sphere®
- Registration Number
- NCT03446391
- Lead Sponsor
- Medacta International SA
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
- Patients necessitating primary Total Knee Replacement
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
- Previous osteotomy around the knee
- Ligament instability likely to require higher level of constraint
- Previous infection or inflammatory disease
- Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kinematic alignment with GMK Sphere® Kinematic alignment Patients enrolled prospectively with surgeries planned to get kinematic alignment Kinematic alignment with GMK Sphere® GMK Sphere® Patients enrolled prospectively with surgeries planned to get kinematic alignment Mechanical alignment with GMK Sphere® Mechanical alignment Historical group who had mechanical alignment, match-paired with the prospective group Mechanical alignment with GMK Sphere® GMK Sphere® Historical group who had mechanical alignment, match-paired with the prospective group
- Primary Outcome Measures
Name Time Method Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score 1-year follow-up 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)
- Secondary Outcome Measures
Name Time Method Residual deformity 1-year follow-up The residual deformity is evaluated by long axis Xray analysis: HKA angle
Patient functional improvement, satisfaction and symptoms 1-year follow-up The functional improvement, satisfaction and symptoms is the sum of the following subscores of the new KSS: "Functional Activities", "Patient Satisfaction" and "Symptoms"
Flexion-extension contracture 1-year follow-up The flexion-extension contracture is evaluated by a subscore of the new KSS: "Joint motion"
Self-reported pain, function and stiffness 1-year follow-up These aspects are evaluated through KOOS score
Ability to forget about artificial joint 1-year follow-up Through the use of the Forgotten Joint Score
Trial Locations
- Locations (1)
St. Vinzenz Krankenhaus Brakel
🇩🇪Brakel, North Rhine-Westphalia, Germany