Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment

Knee Arthroplasty, Total Clinical Trial

— KneeKG Sphere  

Official title:

Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226339
• Other study ID #: 69HCL19_0497
• Secondary ID: 2019-A02288-49
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: March 7, 2029

Study information

• Verified date: August 2022
• Source: Hospices Civils de Lyon
• Contact: Sebastien Lustig, Pr
• Phone: 4 26 10 92 98
• Email: sebastien.lustig[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: March 7, 2029
• Est. primary completion date: March 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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