Informations générales (source: ClinicalTrials.gov)

NCT03975673 Statut inconnu
Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
Interventional
  • Arthrite
  • Maladies articulaires
N/A
Centre de l'arthrose, Paris (Voir sur ClinicalTrials)
janvier 2020
juillet 2023
29 juin 2024
Background - In the 19th century, Sir John Charnley successfully introduced total joint replacements for hips. In order to prevent implant fixation failure and accelerated polyethylene wear, it was initially recommended that implants were systematically positioned in a "biomechanically-friendly" way, which disregarded most of the individual anatomy (medialized acetabular cup, systematized cup version and inclination, etc.) - While those initial surgical techniques made popular and clinically successful total joint replacements, many complications (aseptic loosening, pain, excessive wear) have remained and mainly the persistence of frequent instability after THA. In response to those complications, many improvements were developed in the area of joint replacement over the last few decades, with one the most recent dating from 2017 and being the development of a surgical technique Rationale - The kinematic alignment (KA) technique for total hip arthroplasty (THA) aims at restoring the acetabular center of rotation and as much as possible the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark. Also, the technique aims (1) at making personalized choice for the hip component design, (2) at defining the cup positioning, and (3) at sometimes considering additional spine surgery based on the assessment of the individual spine-hip relation. - KA techniques for hip replacements are relatively new, likely to become popular over time, and their true value remains to be determined.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
ESPACE JEUNES ADULTES DE PARIS cedric maillot, md En recrutement IDF Contact (sur clinicalTrials)

Critères

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Inclusion Criteria:

- Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR).

- > 18 years-old with no upper age limit

- Affiliated to a social security scheme



- Pregnant or lactating women or in age to procreate without contraceptive treatment

- History of mental illness or neurological deficit or adults lacking capacity to
consent for themselves

- Prisoners or young offenders

- Persons who might not adequately understand verbal explanations or written
information given in French, or who have special communication needs

- Subjects having been or being frequently x-ray examination

- Heart failure with risk of exercise angina or comorbidity(ies) significantly
affecting patient function

- Any participants who are involved in current research or have recently been involved
in any research prior to recruitment.