Essais cliniques sur Remplacement du genou, Surgical Robotics - Registre des essais cliniques

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.

Type d'étude

Observationnel

Inscription (Réel)

128

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Arizona
  - Phoenix, Arizona, États-Unis, 85016
    - Hedley Orthopedics
- California
  - Santa Barbara, California, États-Unis, 93105
    - Santa Barbara Cottage Hospital
- Michigan
  - Battle Creek, Michigan, États-Unis, 49015
    - Bronson Orthopedic Specialists
- Ohio
  - New Albany, Ohio, États-Unis, 43054
    - OrthoNeuro New Albany
- Pennsylvania
  - Philadelphia, Pennsylvania, États-Unis, 19107
    - Rothman Institute

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition

La description

Inclusion Criteria:

Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.

Exclusion Criteria:

Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
Subject, in the opinion of the Investigator, was morbidly obese.
Subject, in the opinion of the Investigator, was contraindicated for UKR.
Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
Subject (prospective subjects only) is a prisoner.

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship Délai: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively	Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.	Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments Délai: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively	Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function. Objective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points. Higher scores indicated a better outcome.	Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments Délai: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively	Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health). Domain Scores: Physical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25 Sub-domain Scores: Physical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10 Transformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100 A higher score indicates a better outcome.	Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Preoperative Evaluation of Efficacy Based on Radiographic Findings Délai: Preoperative (Baseline)	Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	Preoperative (Baseline)
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings Délai: 6 months postoperatively	Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	6 months postoperatively
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings Délai: 12 months postoperatively	Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	12 months postoperatively
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings Délai: 18 months postoperatively	Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	18 months postoperatively
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings Délai: 24 months postoperatively	Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	24 months postoperatively
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings Délai: 30 months postoperatively	Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	30 months postoperatively
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings Délai: 36 months postoperatively	Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.	36 months postoperatively

Collaborateurs et enquêteurs

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

Parrainer

Smith & Nephew, Inc.

Les enquêteurs

Directeur d'études: Beate Hanson, MD, PhD, Smith & Nephew, Inc.

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 (Réel)

10 juillet 2017

Achèvement primaire (Réel)

29 novembre 2017

Achèvement de l'étude (Réel)

29 novembre 2017

Dates d'inscription aux études

Première soumission

2 mars 2017

Première soumission répondant aux critères de contrôle qualité

2 mars 2017

Première publication (Réel)

7 mars 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 mai 2022

Dernière vérification

1 décembre 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

16-NPFS-11

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 .

A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)

A Retrospective Study of the Navio™ Robotic-assisted Surgical System