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Journey II BCS Observational Study


- candidate number15777
- NTR NumberNTR4281
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2013
- Secondary IDsR11009-7 
- Public TitleJourney II BCS Observational Study
- Scientific TitleA Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Study to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System
- ACRONYM
- hypothesisThe goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. ¡§Success¡¨ is defined as 10 year survival of the study device without revision for any reason.

A non-inferiority test of the cumulative percent success (defined here above) in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate will be the primary test of efficacy in this study. The null hypothesis is H0: Pi0 - Pi > or = 0.05 and the alternative hypothesis is Ha: Pi0 -ĈPi < 0.05.
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty
- Inclusion criteria• subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing
• subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
• subject is of legal age to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the EC approved informed consent form
• subject plans to be available through ten (10) years postoperative follow-up
- Exclusion criteria• age > 75 years
• subjects with immunosuppressive disorders
• subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation (including but not limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral hip arthritis resulting in flexion contracture)
• patient has undergone a previous major surgery to the study knee (including but not limited to osteotomy, fracture fix, medial or lateral ligament surgery)
• subject has active infection or sepsis (treated or untreated)
• At the time of enrollment, subject has one or more of the following athroplasties that are not fully healed and well-functioning, as determined by the investigator:
o ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
o contralateral primary total knee or unicondylar knee arthroplasty
• subject has presence of malignant tumor, metastatic, or neoplastic disease
• subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
• subject has inadequate bone stock to support the device (severe osteopenia, family history of severe osteoporosis or osteopenia)
• subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• subject has a BMI>40
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate31-dec-2025
- Target number of participants167
- InterventionsOnly patients who will be treated with the Journey II BCS knee prosthesis as part of their normally planned care will qualify for this study.
- Primary outcome• Revision for any reason For the purpose of this study, “revision” will be defined as the exchange of one or more components.
- Secondary outcome• EQ-5D
• 2011 KSS
• Adverse events
• Radiographic evaluation
- TimepointsPreop
3 Month (± 2W)
1Year (± 2M)
2 Year (± 3M)
5 Year (± 6M)
10 Year (± 6M)
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Fleur Derdeyn
- CONTACT for SCIENTIFIC QUERIES Fleur Derdeyn
- Sponsor/Initiator Sint Franciscus Gasthuis, Smith & Nephew Orthopaedics AG
- Funding
(Source(s) of Monetary or Material Support)
Smith & Nephew
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-dec-2013 - 18-dec-2013


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