No registrations found.
ID
Source
Health condition
total knee arthroplasty
degenerative joint disease
Sponsors and support
Oberneuhofstrasse 10d
6340 Baar
Switzerland
Oberneuhofstrasse 10d
6340 Baar
Switzerland
Intervention
Outcome measures
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
Background summary
N/A
Study objective
The 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.
Study design
Preop
3 Month (± 2W)
1Year (± 2M)
2 Year (± 3M)
5 Year (± 6M)
10 Year (± 6M)
Intervention
Only patients who will be treated with the Journey II BCS knee prosthesis as part of their normally planned care will qualify for this study.
Hector Henneaulaan 366
Fleur Derdeyn
Zaventem 1930
Belgium
0032 2 702 29 85
Fleur.derdeyn@smith-nephew.com
Hector Henneaulaan 366
Fleur Derdeyn
Zaventem 1930
Belgium
0032 2 702 29 85
Fleur.derdeyn@smith-nephew.com
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4130 |
| NTR-old | NTR4281 |
| Other | : R11009-7 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |