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- Klinische proef NCT02820766
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.
To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.
Studie Overzicht
Toestand
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Maryland
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Annapolis, Maryland, Verenigde Staten, 21401
- Anne Arundel Medical Cneter
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Oregon
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Eugene, Oregon, Verenigde Staten, 97401
- Slocum Research & Educational Foundation
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Pennsylvania
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State College, Pennsylvania, Verenigde Staten, 16801
- University Orthopaedic Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith & Nephew Posterior Stabilized Knee System
- Will be initiating outpatient PT ≤ 7 days post-operatively
- Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
- Has pre-operative ROM ≥ 90°
- Is skeletally mature in the PI judgment
- Is 21 years of age of older
- Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires
- Has consented to participate in the study by signing the IRB/EC approved informed consent for the study
- Agrees to follow post- operative physical therapy program
Exclusion Criteria:
- Significant preoperative varus or valgus deformities (>15º)
- Has received a constrained or deep dish tibial insert
- Morbid obesity (BMI > 40)
- Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
- Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
- Fibromyalgia requiring treatment
- Current or impending incarceration or is a prisoner
- In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
- Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement
- Requires a Legally Authorized Representative to consent to the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Journey II BCS Knee
Physical Therapy Observational
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All Other Posterior Stabilized Knees
Physical Therapy Observational
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
Tijdsspanne: ≤7 days of surgery
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The absolute Range of Motion of index knee will be compared between groups
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≤7 days of surgery
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Beate Hanson, MD, Smith & Nephew, Inc.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Journey II BCS CMS Study
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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