Matched Pair Study - Kinematic vs Mechanical Alignment

Osteoarthritis, Knee Clinical Trial

Official title:

Matched Pair Study to Assess Influence of Kinematic Versus Mechanical Alignment in Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446391
• Other study ID #: P02.010.18
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: May 18, 2019

Study information

• Verified date: March 2019
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 18, 2019
• Est. primary completion date: May 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).

2. Patients necessitating primary Total Knee Replacement

3. 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:

1. Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.

2. Previous osteotomy around the knee

3. Ligament instability likely to require higher level of constraint

4. Previous infection or inflammatory disease

5. 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.

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases
• Osteoarthritis, Knee

Intervention

Procedure:
• Kinematic alignment
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.
• Mechanical alignment
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

Device:
• GMK Sphere®
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.

Locations

Country	Name	City	State
Germany	St. Vinzenz Krankenhaus Brakel	Brakel	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Residual deformity	The residual deformity is evaluated by long axis Xray analysis: HKA angle	1-year follow-up
Secondary	Flexion-extension contracture	The flexion-extension contracture is evaluated by a subscore of the new KSS: "Joint motion"	1-year follow-up
Secondary	Self-reported pain, function and stiffness	These aspects are evaluated through KOOS score	1-year follow-up
Secondary	Ability to forget about artificial joint	Through the use of the Forgotten Joint Score	1-year follow-up