- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03072459
A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)
A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85016
- Hedley Orthopedics
-
-
California
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Santa Barbara, California, Forente stater, 93105
- Santa Barbara Cottage Hospital
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-
Michigan
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Battle Creek, Michigan, Forente stater, 49015
- Bronson Orthopedic Specialists
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-
Ohio
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New Albany, Ohio, Forente stater, 43054
- OrthoNeuro New Albany
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Rothman Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Beate Hanson, MD, PhD, Smith & Nephew, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 16-NPFS-11
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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