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Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

128

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Smith & Nephew, Inc.

Onderzoekers

Studie directeur: Beate Hanson, MD, PhD, Smith & Nephew, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juli 2017

Primaire voltooiing (Werkelijk)

29 november 2017

Studie voltooiing (Werkelijk)

29 november 2017

Studieregistratiedata

Eerst ingediend

2 maart 2017

Eerst ingediend dat voldeed aan de QC-criteria

2 maart 2017

Eerst geplaatst (Werkelijk)

7 maart 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

2 mei 2022

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

16-NPFS-11

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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

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