Actively Recruiting

Phase Not Applicable
Age: 55Years - 80Years
All Genders
ID04226339

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

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the walking patterns after total knee arthroplasty (TKA) in adults aged 55 to 80 with disabling femorotibial osteoarthritis. This study compares two types of knee replacements: one that aligns the knee mechanically at 180 degrees and another that uses kinematic alignment to restore the patient's original knee position. The goal is to understand how these approaches affect knee function and patient satisfaction, as about 20% of patients remain dissatisfied after TKA. The study involves randomly assigning participants to receive either a total knee arthroplasty with kinematic alignment or mechanical alignment. Both surgeries use a SPHERE prosthesis to replace the knee. The kinematic alignment group will have the prosthesis set to mimic their preoperative knee deformity, while the mechanical alignment group will have the prosthesis set to a standard 180-degree alignment. This approach aims to assess the impact of these surgical techniques on knee biomechanics. Participants will be monitored over time, with walking tests and knee function assessments conducted at 12 months and up to 60 months after surgery. Researchers will measure changes in walking speed, knee angles, knee motion, functional recovery, and patient ability to forget the prosthesis. Safety and complications will also be recorded. The study offers thorough follow-up to evaluate long-term outcomes of these knee replacement methods.

CONDITIONS

Brief 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 aged 55 to 80 years
  • 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 support weight on one leg for 1 minute and walk at least 0.8 km/h for 5 minutes
  • Affiliated with a social security system
  • Able to understand and fulfill study requirements
Not Eligible

You will not qualify if you...

  • Bilateral total knee arthroplasty
  • Revision of a unicompartmental prosthesis
  • History of femoral or tibial fracture
  • History of femoral or tibial osteotomy
  • Additional procedures during surgery (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 participation
  • Adults under legal protection measures
  • Pregnant or breastfeeding women
  • Participation in another clinical trial that may affect this study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week or until discharge

Participants undergo total knee arthroplasty with either kinematic alignment or mechanical alignment using a SPHERE prosthesis.

1 surgical procedure and immediate hospital care

Post-operative Follow-up

Duration - Up to 60 months

Participants are monitored for recovery, knee function, and complications after surgery.

Regular follow-up visits over 12 months and extended assessments up to 60 months

Trial Site Locations

Total: 1 location

1

Hôpital de la Croix Rousse

Lyon, France, 69004

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Research Team

S

Sebastien Lustig, Pr

J

Julien Berthiller

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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