- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02042586
Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis.
Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".
To this end, the study will take place as follows:
Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Dijon, France, 21079
- CHU de Dijon
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Control group:
- Subjects who have provided written informed consent
- Subjects covered by the national health insurance scheme
- Men or women aged between 25 and 85 years
- able to understand simple instructions and packaging instructions and able to give informed consent
Patients group:
- Patients who have provided written informed consent
- Patients covered by the national health insurance scheme
- Men or women aged between 25 and 85 years
- able to understand simple instructions and packaging instructions and to give their informed consent
- Suffering from hip osteoarthritis defined according to ACR criteria
- Most recent radiography examination less than 6 months earlier
- Radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification
- Presenting with an indication for total hip replacement, according to the surgeon's usual criteria
Exclusion Criteria:
Control group:
- Hip osteoarthritis or other arthrosis in the lower limbs
- Pregnant or breast-feeding women
- Disorders that may interfere with gait analysis
- Disorder that may be destabilized by gait analysis
- Neurological disease and/or motor neuron disease
Patients group:
- Contra-indication for total hip replacement
- Repeat surgery for total hip replacement
- Impossibility to use a standard implant
- Pregnant or breast-feeding women
- Inflammatory flare of the hip osteoarthritis
- Disorder that may interfere with gait analysis
- Disorder that may be destabilized by gait analysis
- Rapidly destructive hip osteoarthritis
- Neurological disease and/or motor neuron disease
- Hip dysplasia requiring THR to be completed using a graft
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Les contrôles
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Les patients
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Degree of patient statisfaction
Délai: Before and between 6 months and 1 year after total hip replacement
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Before and between 6 months and 1 year after total hip replacement
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TROUILLOUD AOI 2007
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