Matched Pair Study - Kinematic Vs Mechanical Alignment

NCT03446391 | Completed

• 1 other identifier: P02.010.18
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Joint Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient functional improvement, satisfaction and symptoms

  1-year follow-up

• Residual deformity

  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

Study Arms (2)

Kinematic alignment with GMK Sphere®

Patients enrolled prospectively with surgeries planned to get kinematic alignment

Procedure: Kinematic alignment; Device: GMK Sphere®

Mechanical alignment with GMK Sphere®

Historical group who had mechanical alignment, match-paired with the prospective group

Procedure: Mechanical alignment; Device: GMK Sphere®

Interventions

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.

Kinematic alignment with GMK Sphere®

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

Mechanical alignment with GMK Sphere®

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.

Kinematic alignment with GMK Sphere®; Mechanical alignment with GMK Sphere®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

St. Vinzenz Krankenhaus Brakel

Brakel, North Rhine-Westphalia, 33034, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 26, 2018
• Study Start: January 2, 2018
• Primary Completion: May 18, 2019
• Study Completion: May 18, 2019
• Last Updated: December 16, 2024

Record last verified: 2019-03

Locations

DE (1)