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Completed

NCT Number: NCT03446391

Matched Pair Study - Kinematic Vs Mechanical Alignment

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Disease Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vinzenz Krankenhaus Brakel

Brakel, North Rhine-Westphalia, 33034, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. 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

  1. Patient functional improvement, satisfaction and symptoms

    Time frame: 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"

  2. Residual deformity

    Time frame: 1-year follow-up

    The residual deformity is evaluated by long axis Xray analysis: HKA angle

  3. Flexion-extension contracture

    Time frame: 1-year follow-up

    The flexion-extension contracture is evaluated by a subscore of the new KSS: "Joint motion"

  4. Self-reported pain, function and stiffness

    Time frame: 1-year follow-up

    These aspects are evaluated through KOOS score

  5. Ability to forget about artificial joint

    Time frame: 1-year follow-up

    Through the use of the Forgotten Joint Score

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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