The goal of this study is to determine functional outcome and patient satisfaction between the Journey II and the Genesis II prosthesis. The results of this research will help optimize prosthesis selection, possibly resulting in higher patient…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective of this study is to determine differences in short term
functional outcome and patients perspective of outcome following Total Knee
Arthroplasty between the two different total knee prosthesis, measured using
the Oxford Knee Score (OKS).
Secondary outcome
* Range of motion of the knee measured using a goniometer
* Pain relief, functional abilities, satisfaction and fulfilment of
expectations using the Knee Society Score (KSS), KOOS-PS, the Numerical Scale
for Pain and Satisfaction (NRS-pain, NRS-satisfaction).
* Overall quality of life using the EQ-5D questionnaire
* The number of adverse events or the need for revision
* The length of hospital stay measured in days
Background summary
Despite substantial advances in primary Total Knee Arthroplasty (TKA) in the
recent decades, the level of patient satisfaction one year after surgery
(81-89%) shows room for improment and is thought to increase when using guided
motion prosthesis designed to mimic natural kinematics. The Journey II BCS is a
new implant design which follows the principles of guided motion to reproduce
natural knee kinematics. The natural kinematics are claimed to produce superior
functional and clinical outcome and thus higher patient satisfaction levels.
We want to perform a randomized control trial with a follow-up of 1 year to
compare patient satisfaction and functional and clinical outcomes between the
Journey II BCS and the Genesis II total knee prosthesis to determine whether
these claims are accurate. We choose the Genesis II prosthesis for our control
group because it*s a proven prosthesis with low revision rates, and it*s the
most frequent used prosthesis in the Netherlands.
The null hypothesis is that there is no significant difference in short-term
patient satisfaction, and functional and clinical outcomes after primary total
knee arthroplasy using either the Journey II or the Genesis II prosthesis. This
study distinguishes itself from current ongoing studies worldwide, which are
all observational studies, by randomizing and comparing the new prosthesis with
a widely used and proven prosthesis.
See the appendix in the additional remarks section 'J' for current ongoing
trials.
Study objective
The goal of this study is to determine functional outcome and patient
satisfaction between the Journey II and the Genesis II prosthesis. The results
of this research will help optimize prosthesis selection, possibly resulting in
higher patient satisfaction
Study design
Prospective, randomised, single centre, single-blinded intervention research
Intervention
Both groups will undergo total knee arthroplasty. Patients in the intervention
group will receive a Journey II prosthesis. Patients in the control group wil
receive a Genesis II prosthesis.
Study burden and risks
Patients will have to fill out above mentioned questionnaires during regular
policlinical appointments.Additionally they will be asked to fill out
questionnaires pre-operatively and at 24 months post-op. For more information I
refer you to chapter 7.8 of the studyprotocol for the schedule of events.
Early single surgeon series have shown that the Journey II is a safe prosthesis
which might score better in functional and clinical outcomes when compared to
conventionel prosthesis designs. The Journey is CE-marked and roughly 75.000
Journey II prosthesis have been implanted worldwide since 2012. Current data
shows revision rates do no significantly differ from national revision rates.
This shows that usage of the Journey II holds no additional risks when compared
to conventional total knee arthroplasty.
For the summary of findings from early single surgeon series I refer you to
section 5.2 of the studyprotocol.
Olof Palmestraat 20
Delft 2616LS
NL
Olof Palmestraat 20
Delft 2616LS
NL
Listed location countries
Age
Inclusion criteria
1. Subject requires primary total knee arthroplasty due to degenerative joint disease
2. Subject is 18-80 years of age and skeletally mature
3. Subject 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
4. Subject plans to be available through 2 years postoperative follow-up
5. Subject is capable of understanding the Dutch language
6. Subject is able to consent to participate by signing the informed consent form
Exclusion criteria
1. subject has severe pronation of the ipsilateral foot or any other lower extremity or hip condition causing abnormal ambulation
2. patient has undergone a previous osteotomy or fracture fix
3. subject has active infection or sepsis (treated or untreated)
4. subject has presence of malignant tumor, metastatic, or neoplastic disease
5. subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget*s or Charcot*s disease, vascular insufficiency, severe muscular atrophy, uncontrolled diabetes, severe renal insufficiency or neuromuscular disease)
6. subject has inadequate bone stock to support the device
7. subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL63782.098.17 |