The purpose of this study is to document the short-, mid- and long-term safety and efficacy of the Journey II BCS knee prosthesis. The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Revision for any reason (*revision* will be defined as the exchange of one or
more components)
Secondary outcome
- EQ-5D
- 2011 KSS
- Adverse events
- Radiographic evaluation
Background summary
The continuous evaluation of the safety and efficacy of medical devices that
are brought onto the market by the manufacturer is an obliged quality
requirement, imposed by the European Directives. Smith & Nephew (Smith & Nephew
Orthopedics AG, Baar, Zwitserland) initiates this study to evaluate the safety
and efficacy of the Journey II BCS knee prosthesis with patients who underwent
total knee arthroplasty (how well is its performance and to which extent do
adverse events occur?) up to 10 years after surgery.
Study objective
The purpose of this study is to document the short-, mid- and long-term safety
and efficacy of the Journey II BCS knee prosthesis. 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.
Primary endpoint of the study is therefore "Revision for any reason" and for
the purpose of this study, *revision* will be defined as the exchange of one or
more components.
Study design
This is a multicenter, prospective, observational study to collect relevant
clinical data from 167 patients implanted with the Journey II BCS Knee System.
Data from eligible patients, who have provided written and informed consent for
the collection of their coded data, will be recorded from the patient*s medical
file on specially designed case report forms (CRF*s).
Intervention
Journey II BCS Total Knee System, including patella resurfacing.
Study burden and risks
Patients will not be burden with excessive risks in case of participation. Most
of the data will be collected during routine clinical assessments. Patients
will be asked to fill out some questionnaires (KSS & EQ-5d) at each visit.
Furthermore, they will be asked to visit the clinic at 2, 5 and 10 years after
surgery. The advantage is that the patient is followed closely. If for the
5Year follow-up visit, a patient refuses to come to the hospital or is unable
to due to COVID-19, a telephone follow-up assessment will be performed as to
prioritize safety of patients and study personnel over the study needs.
Next, the patient will be exposed to ionizing radiation due to the X-rays that
will be taken from the knee joint. The total effective dose of this radiation
is acceptable.
Finally, the information we get from this study may help improve the treatment
of people that need to undergo total knee arthroplasty.
Theilerstrasse 1A
Zug 6300
CH
Theilerstrasse 1A
Zug 6300
CH
Listed location countries
Age
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 (>18y), 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
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 arthroplasties that are
not fully healed and well-functioning, as determined by the investigator
- subject has presence of malignant tumor, metastatic, or neoplastic disease
- subject has conditions that may interfere with the TKA survival or outcome
- 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 |
|---|---|
| Other | ClinicalTrials.gov, Ref Nr: NCT02211794 |
| CCMO | NL46006.048.13 |