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

NCT04226339 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-08-23

No results posted yet for this study

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.

Conditions

  • Knee Arthroplasty, Total

Interventions

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Sebastien Lustig, Pr · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2025-03-07
Completion
2029-03-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04226339 on ClinicalTrials.gov