Matched Pair Study to Assess Influence of Kinematic Versus Mechanical Alignment in Total Knee Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Medacta International SA
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score
Time Frame: 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 Outcomes
- Residual deformity(1-year follow-up)
- Patient functional improvement, satisfaction and symptoms(1-year follow-up)
- Flexion-extension contracture(1-year follow-up)
- Self-reported pain, function and stiffness(1-year follow-up)
- Ability to forget about artificial joint(1-year follow-up)