- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03072459
A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)
A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85016
- Hedley Orthopedics
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California
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Santa Barbara, California, Vereinigte Staaten, 93105
- Santa Barbara Cottage Hospital
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Michigan
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Battle Creek, Michigan, Vereinigte Staaten, 49015
- Bronson Orthopedic Specialists
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Ohio
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New Albany, Ohio, Vereinigte Staaten, 43054
- OrthoNeuro New Albany
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
- Rothman Institute
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Zeitfenster: 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.
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Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
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Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Zeitfenster: 6 months postoperatively
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Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
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6 months postoperatively
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Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Zeitfenster: 12 months postoperatively
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Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
12 months postoperatively
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Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Zeitfenster: 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
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Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Zeitfenster: 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
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Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Beate Hanson, MD, PhD, Smith & Nephew, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 16-NPFS-11
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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