Actively Recruiting

Phase Not Applicable
Age: 55Years - 80Years
All Genders
NCT04226339

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

Led by Hospices Civils de Lyon · Updated on 2022-08-23

104

Participants Needed

1

Research Sites

443 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both sexes
  • Adults between 55 and 80 years old
  • Diagnosis of internal or global disabling femorotibial gonarthrosis
  • Indication for first unilateral total knee arthroplasty using a Sphere type prosthesis (Medacta)
  • Constitutional varus deformity between 3° and 10°
  • Able to perform KneeKG walking test: unipodal support for 1 minute and run for 5 minutes at minimum speed of 0.8 km/h
  • Affiliated to a social security system
  • Able to understand and meet study requirements
Not Eligible

You will not qualify if you...

  • Bilateral total knee arthroplasty
  • Knee arthroplasty to replace a unicompartmental prosthesis
  • History of femoral or tibial fracture
  • History of femoral or tibial osteotomy
  • Additional surgical procedures at the same time (e.g., allograft, osteotomy)
  • External femorotibial gonarthrosis
  • Hip Knee Ankle angle greater than 178°
  • Constitutional deformity greater than 10°
  • Refusal to participate
  • Legal or psychiatric restrictions on liberty
  • Adults under legal protection
  • Pregnant or breastfeeding women
  • Participation in another clinical trial that may interfere with this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hôpital de la Croix Rousse

Lyon, France, 69004

Actively Recruiting

Loading map...

Research Team

S

Sebastien Lustig, Pr

CONTACT

J

Julien Berthiller

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here