Kinematic Versus Mechanical Alignment in Total Knee Replacement

NCT ID: NCT04384913

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2026-01-30

Brief Summary

This prospective controlled double-blind randomized study compares kinematic and mechanical alignment in TKA (Total knee arthroplasty). A total of 120 patients will be included and the surgery will be performed using CT based 3D printed PSI(Patient Specific Instruments) Cutting guides.

Detailed Description

Total knee arthroplasty (TKA) is known, to significantly improve function and satisfaction in arthritic knee patients; nevertheless, a substantial percentage of these patients are not fully satisfied. Thus, several authors reported significantly improved outcomes after slightly under correcting varus knees after TKA. The concept of kinematic alignment (KA) even more addresses the patient´s individual anatomy with three-dimensional restoration of individual axes, joint lines and joint envelope of laxity. The aim of this prospective randomized study was to demonstrate equivalence between mechanical and kinematic alignment in restoring knee function in terms of subjective and objective outcomes.

In this prospective randomized controlled double-blind study 120 patients with osteoarthritic knees will be treated with a Medial Pivot TKA (Medacta Sphere GMK). The patients are divided into two groups. Group A receive the TKA using mechanical alignment principles, group B receive the kinematic alignment. The surgical technique was equal in both groups. CT-based 3D printed PSI cutting blocks were used for the saw cuts. Pre and postoperative standard x-rays were performed. To determine the subjective and objective outcomes the OKS(Oxford Knee Score), the KSS(Knee Society Sore), the FJS-12(Forgotten Joint Score) and the WOMAC Score were collected.

Conditions

Total Knee Replacement

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MA (mechanical alignment)

Patients in group MA (mechanical alignment) will be operated according to mechanical implantation technique. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation.

No interventions assigned to this group

KA (kinematic alignment)

Patients in group KA (kinematic alignment) will be operated according to kinematic implantation technique. The kinematic cutting blocks will be designed to resurface the femoral and tibial bones to restore each patient´s pre-arthritic anatomy and Joint line. Based on a available CT dat the prearthritic anatomy is reconstructed by compensating bone defects and restoring the physiological cartilage height of 1,7mm. Femoral Flexion is evaluated by the anterior Cortex of the distal femur, tibia slope is defined to 3° due to ACL (Anterior Cruciate Ligament) loss, but cab be adapted during surgery.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Symptomatic osteoarthritis of the knee
• Primary TKA
• UCLA Score (University of California, Los Angeles Score)>/= 4
• mMPTA: 85°- 90°
• Sum of mMPTA(mechanical medial proximal tibial angle) and mLDFA(mechanical lateral distal femoral angle) between 3°varus and 2°valgus from neutral

Exclusion Criteria

• Minor Patient
• Pregnant or breast feeding woman
• Difference in the radius of medial and lateral condyles >2mm
• Previous osteotomy around the knee
• BMI >40
• Ligament instability likely to require higher level of constraint
• Previous infection or inflammatory disease
• Any Patient who cannot or will not provide informed consent for participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Max Ettinger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Locations

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, Germany

Countries

Germany

Other Identifiers

A2-2017-KAvsMA

Identifier Type: -

Identifier Source: org_study_id