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Conservateur versus opératoire - Première luxation de la rotule

16 septembre 2026 mis à jour par: Columbia University

Prise en charge conservatrice versus chirurgicale des premières luxations de la rotule

There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Aperçu de l'étude

Description détaillée

Long term sequalae of first-time patellar dislocations include recurrent knee instability, osteoarthritis, and a decreased quality of life, and yet there is no consensus on the best management for these patients. Despite an increasing trend toward investigating operative vs non-operative management of primary patellar dislocations, scarce level-1 evidence exists comparing the two treatment modalities. Indeed, the few meta-analyses suggesting improved outcomes of operative treatment for first time patellar dislocations mainly utilize retrospective cohort studies. A randomized-controlled trial of 39 patients with primary patellar dislocations with a mean age of 24 (21 operative vs 18 non-operative), found decreased rates of recurrent knee instability after a mean follow up of 44 months (0% in operative vs 35% in non-operative), and a higher Kujala knee score (88.9 in operative vs 70.8 in non-operative; p=0.001). A controlled but non-randomized prospective controlled trial among 69 patients with a mean age of 18, (30 operative vs 39 non-operative), found lower rates of recurrent knee instability after a mean follow up of 24 months (0% in operative vs 20.5% in non-operative and a higher Kujala knee score (86.3 in operative group vs 80.03 in non-operative; p <0.05).The scarce randomized, prospective data investigating the appropriate management in primary patellar dislocations underscores the importance of the current study in providing high-quality evidence to the debate of how to best manage primary patellar dislocations. This study aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • age 12 and older
  • patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service
  • patients who experience a first-time patella dislocation

Exclusion Criteria:

  • coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention
  • previous knee surgery
  • knee instability prior to injury
  • inability or unwillingness to adhere to study participate
  • lost to follow up

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Operative Group

This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)

Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.

Comparateur actif: Non-operative group

This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.

Physical therapy by following a specific regimen.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Kujala Questionnaire Score at 2 weeks
Délai: Baseline and 2 weeks

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 2 weeks
Change in Kujala Questionnaire Score at 6 weeks
Délai: Baseline and 6 weeks

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 6 weeks
Change in Kujala Questionnaire Score at 3 months
Délai: Baseline and 3 months

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 3 months
Change in Kujala Questionnaire Score at 6 months
Délai: Baseline and 6 months

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 6 months
Change in Kujala Questionnaire Score at 1 year
Délai: Baseline and 1 year

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 1 year
Change in Kujala Questionnaire Score at 2 years
Délai: Baseline and 2 years

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 2 years
Change in Kujala Questionnaire Score at 5 years
Délai: Baseline and 5 years

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 5 years
Change in Kujala Questionnaire Score at 10 years
Délai: Baseline and 10 years

The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

Baseline and 10 years
Time to first re-dislocation
Délai: Up to 10 years

Time to first re-dislocation following intervention, measured in weeks

Up to 10 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
Délai: Baseline and 2 weeks

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
Délai: Baseline and 6 weeks

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
Délai: Baseline and 3 months

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
Délai: Baseline and 6 months

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
Délai: Baseline and 1 Year

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
Délai: Baseline and 2 Years

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
Délai: Baseline and 5 Years

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
Délai: Baseline and 10 Years

A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.

Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
Délai: Baseline and 2 weeks

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
Délai: Baseline and 6 weeks

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
Délai: Baseline and 3 Months

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 3 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
Délai: Baseline and 6 Months

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 6 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
Délai: Baseline and 1 Year

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
Délai: Baseline and 2 Years

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
Délai: Baseline and 5 Years

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
Délai: Baseline and 10 Years

A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.

Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
Délai: Baseline and 2 weeks

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
Délai: Baseline and 6 weeks

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
Délai: Baseline and 3 months

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
Délai: Baseline and 6 months

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
Délai: Baseline and 1 year

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 1 year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
Délai: Baseline and 2 years

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 2 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
Délai: Baseline and 5 years

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 5 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
Délai: Baseline and 10 years

A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.

Baseline and 10 years
Percentage of participants who re-dislocate their knee after treatment at each time point within each group
Délai: 2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

Percentage of group that experienced re-dislocation after treatment starts at each time point

2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Time to return to full activity or sports for each group
Délai: Up to 10 years

Time from treatment initiation to full return to pre-injury activity levels in each group, measured in weeks

Up to 10 years
Change in the Banff Patella Instability Instrument at 2 weeks
Délai: Baseline and 2 weeks

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 2 weeks
Change in the Banff Patella Instability Instrument at 6 weeks
Délai: Baseline and 6 weeks

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 6 weeks
Change in the Banff Patella Instability Instrument at 3 months
Délai: Baseline and 3 months

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 3 months
Change in the Banff Patella Instability Instrument at 6 months
Délai: Baseline and 6 months

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 6 months
Change in the Banff Patella Instability Instrument at 1 year
Délai: Baseline and 1 year

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 1 year
Change in the Banff Patella Instability Instrument at 2 years
Délai: Baseline and 2 years

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 2 years
Change in the Banff Patella Instability Instrument at 5 years
Délai: Baseline and 5 years

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 5 years
Change in the Banff Patella Instability Instrument at 10 years
Délai: Baseline and 10 years

Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.

Baseline and 10 years
Change in Norwich Patellar Instability Score at 2 weeks
Délai: Baseline and 2 weeks

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 2 weeks
Change in Norwich Patellar Instability Score at 6 weeks
Délai: Baseline and 6 weeks

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 6 weeks
Change in Norwich Patellar Instability Score at 3 months
Délai: Baseline and 3 months

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 3 months
Change in Norwich Patellar Instability Score at 6 months
Délai: Baseline and 6 months

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 6 months
Change in Norwich Patellar Instability Score at 1 year
Délai: Baseline and 1 year

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 1 year
Change in Norwich Patellar Instability Score at 2 years
Délai: Baseline and 2 years

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 2 years
Change in Norwich Patellar Instability Score at 5 years
Délai: Baseline and 5 years

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 5 years
Change in Norwich Patellar Instability Score at 10 years
Délai: Baseline and 10 years

Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.

Baseline and 10 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: David Trofa, MD, Associate Professor of Orthopaedic Surgery

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2032

Achèvement de l'étude (Estimé)

1 septembre 2032

Dates d'inscription aux études

Première soumission

4 septembre 2022

Première soumission répondant aux critères de contrôle qualité

7 septembre 2022

Première publication (Réel)

9 septembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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