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

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ClinicalTrials.gov Identifier: NCT04226339
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Knee Arthroplasty, Total Procedure: total knee arthroplasty with a kinetic alignment Procedure: total knee arthroplasty with a mechanical alignment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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





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


Secondary Outcome Measures :
  1. femorotibial angle in frontal plan [ Time Frame: 12 months ]
    Comparison between the 2 groups of the frontal femorotibial angle measured by the KneeKG system, 12 months after total knee arthroplasty

  2. sagittal femorotibial angle [ Time Frame: 12 months ]
    Comparison between the 2 groups of the sagittal femorotibial angle measured by the KneeKG system, 12 months after total knee arthroplasty

  3. tibia rotation compared to the femur [ Time Frame: 12 months ]
    Comparison between the 2 groups of the tibia rotation angle compared to femur measured by the KneeKG system, 12 months after total knee arthroplasty

  4. maximal knee flexion [ Time Frame: 12 months ]
    Comparison between the 2 groups of the maximal knee flexion measured by the KneeKG system, 12 months after total knee arthroplasty

  5. maximal knee extension [ Time Frame: 12 months ]
    Comparison between the 2 groups of the maximal knee extension measured by the KneeKG system, 12 months after total knee arthroplasty

  6. knee range motion [ Time Frame: 12 months ]
    Comparison between the 2 groups of the knee range motion measured by the KneeKG system, 12 months after total knee arthroplasty

  7. knee functional recovery [ Time Frame: 12 months ]

    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


  8. Ability of the patient to forget his prosthesis [ Time Frame: 12 months ]

    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


  9. Complications [ Time Frame: 12 months ]
    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

  10. knee functional recovery [ Time Frame: 60 months ]

    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


  11. Ability of the patient to forget his prosthesis [ Time Frame: 60 months ]

    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


  12. Complications [ Time Frame: 60 months ]
    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



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226339


Contacts
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Contact: Sebastien Lustig, Pr 4 26 10 92 98 ext +33 sebastien.lustig@chu-lyon.fr
Contact: Julien Berthiller 4 72 11 80 67 ext +33 julien.berthiller@chu-lyon.fr

Locations
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France
Hôpital de la Croix Rousse
Lyon, France, 69004
Contact: Sebastien Lustig, Pr    4 26 10 92 98 ext +33    sebastien.lustig@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sebastien Lustig, Pr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04226339    
Other Study ID Numbers: 69HCL19_0497
2019-A02288-49 ( Other Identifier: ANSM )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
total knee arthroplasty
prosthesis
kinetic alignment
mechanical alignment