Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment (KneeKG Sphere)

Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment.

The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. A United Kingdom study assessed patient satisfaction in a cohort of 10,000 patients more than one year after TKA: nearly 20% were not satisfied with their TKA.

The knee is indeed a complex articulation that works differently in the three space plans. Current knee prostheses are trying to replicate this biomechanics and get as close as possible to the anatomy of a native knee.

Bellemans et al. found in 250 asymptomatic patients 32% of men with a constitutional varus greater than 3 ° and 17% of women. Restoration of normal knee function can also be achieved by restoring a moderate constitutional deformity present preoperatively. The objective of the femorotibial alignment was dogmatically fixed at 180° (mechanical femorotibial alignment). In recent years, some surgical teams have attempted to reproduce the preoperative constitutional deformity in varus or valgus with the prosthesis. This femorotibial alignment is called kinematic alignment. This kinematic alignment has already been studied in several randomized studies and has demonstrated improved functional scores. However, these studies focused on specific TKA, which are posterior cruciate TKA, and the assessment was subjective through functional scores. In addition, these TKA were often made with patient specific instrumentation (PSI). Some studies have evaluated walking kinematics after TKA with kinematic alignment. But it was again TKA retaining the posterior cruciate ligament.

The investigators would like to prospectively evaluate the restoration of the medially stabilized TKA walking kinematics (medial-stable TKA or ball in socket stability) implanted with a kinematic alignment compared to a mechanical alignment.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Procedure: total knee arthroplasty with a kinetic alignment; Procedure: total knee arthroplasty with a mechanical alignment

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastien Lustig, Pr; Phone Number: +33 4 26 10 92 98; Email: sebastien.lustig@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hopital de la croix rousse
    • Contact: Sebastien Lustig, Pr; Phone Number: +33 4 26 10 92 98; Email: sebastien.lustig@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both sex
• Adults between 55 and 80 years
• Diagnosis of internal or global disabling femorotibial gonarthrosis Indication of total first knee arthroplasty (unilateral), using a Sphere type prosthesis (Medacta)
• Constitutional deformity in varus between 3 ° and 10 °
• Fulfilling the pass conditions of a KneeKG walking test: Unipodal support possible for 1 minute, run for 5 min at a speed of at least 0.8 km / h
• Affiliated to a social security system
• Patients able to understand and fulfill the requirement of the study

Exclusion Criteria:

• TKA bilateral
• TKA to change an Uni-compartmental prosthesis
• History of femoral or tibial fracture
• History of femoral or tibial osteotomy
• Associated gesture at the same time (allograft, osteotomy)
• External femorotibial gonarthrosis
• Angle Hip Knee Ankle > 178 °
• Constitutional distortion> 10 °
• Refusal to participate in the study
• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
• Adults subject to a legal protection measure
• breastfeeding or pregnant women
• Patient already participating to another clinical trial that might jeopardize the current trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: total knee arthroplasty with a kinetic alignment	Procedure: total knee arthroplasty with a kinetic alignment; During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment. it will be set to reproduce the preoperative constitutional deformity in varus or valgus as it was measured before surgery
Active Comparator: total knee arthroplasty with a mechanical alignment	Procedure: total knee arthroplasty with a mechanical alignment; During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment. It will be set to 180° as defined for a mechanical femorotibial alignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of short terms walking speed.	Comparison between the 2 arms, of the walking speed variation between the evaluation before surgery and 1 year after total knee arthroplasty	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
femorotibial angle in frontal plan	Comparison between the 2 groups of the frontal femorotibial angle measured by the KneeKG system, 12 months after total knee arthroplasty	12 months
sagittal femorotibial angle	Comparison between the 2 groups of the sagittal femorotibial angle measured by the KneeKG system, 12 months after total knee arthroplasty	12 months
tibia rotation compared to the femur	Comparison between the 2 groups of the tibia rotation angle compared to femur measured by the KneeKG system, 12 months after total knee arthroplasty	12 months
maximal knee flexion	Comparison between the 2 groups of the maximal knee flexion measured by the KneeKG system, 12 months after total knee arthroplasty	12 months
maximal knee extension	Comparison between the 2 groups of the maximal knee extension measured by the KneeKG system, 12 months after total knee arthroplasty	12 months
knee range motion	Comparison between the 2 groups of the knee range motion measured by the KneeKG system, 12 months after total knee arthroplasty	12 months
knee functional recovery	Comparison between the 2 groups of the knee functional recovery measured by the International Knee Society (IKS) score 12 months after total knee arthroplasty. International Knee Society score : range 0 to 200, a higher score means a better outcome	12 months
Ability of the patient to forget his prosthesis	Comparison between the 2 groups of the patient ability to forget his knee prosthesis measured by the Forgotten Joint score (FJS) 12 months after total knee arthroplasty. Forgotten Joint Score : range 0 to 100, a higher score means a better outcome	12 months
Complications	Comparison between the 2 groups of the proportion of patient with at least one complication including deep infections, prosthesis impairment, knee fracture, surgical revision) during the 12 months after total knee arthroplasty	12 months
knee functional recovery	Comparison between the 2 groups of the knee functional recovery measured by the International Knee Society (IKS) score 60 months after total knee arthroplasty. International Knee Society score : range 0 to 200, a higher score means a better outcome	60 months
Ability of the patient to forget his prosthesis	Comparison between the 2 groups of the patient ability to forget his knee prosthesis measured by the Forgotten Joint score (FJS) score 60 months after total knee arthroplasty. Forgotten Joint Score : range 0 to 100, a higher score means a better outcome	60 months
Complications	Comparison between the 2 groups of the proportion of patient with at least one complication including deep infections, prosthesis impairment, knee fracture, surgical revision) during the 60 months after total knee arthroplasty	60 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sébastien Lustig, Pr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Anticipated): March 7, 2025
• Study Completion (Anticipated): March 7, 2029

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: total knee arthroplasty; prosthesis; kinetic alignment; mechanical alignment
• Other Study ID Numbers: 69HCL19_0497; 2019-A02288-49 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No