The primary objective is to report survivorship, complications and patient reported outcome measures associated with the uncemented ATTUNE rotating platform knee system. Secondary objectives are (1) evaluate patient reported (patellofemoral)…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival rate and complication rate associated with the ATTUNE knee system.
Secondary outcome
- Patient Reported Outcome Measures (PROMS), which are the 'Forgotten Joint
Score 12' and the 'Kujala Anterior Knee Pain Scale' for the current study.
- Physical function and return to sports, which is measured with 'Performance
Based Measurments' (PBM) and 2 1-question questionnaires (Tegner and UCLA
activity rating scale)
- Return to work is assessed by a short self-composed questionnaire, which
evaluates what kind of work the patients do, when they started after surgery
and whether this is the same as their preoperative job.
- A long-leg radiograph is performed 1 year after surgery to assess mechanical
alignment of the prosthesis with consideration of femur and tibia.
- Psychologic factors are assessed with 3 questionnaires preoperative, 5 years
and 10 years postoperative (Pain Self Efficacy Questionnaire (PSEQ); Patient
Health Questionnaire (PHQ-2); Pain Catastrophizing Scale (PCS))
Background summary
Every year, 1.5 million total knee arthroplasties (TKA) are performed worldwide
in patients whose joints have been severely affected by osteoarthritis,
rheumatoid arthritis, or trauma, causing intense pain and loss of function. Due
to the ageing society, these numbers are expected to have increased six-fold to
3.48 million cases annually by 2030. Even though joint replacement provides
satisfactory and durable results for most patients, 20% is thought to still not
be satisfied with their artificial joint. Preoperative mental status and
related pain coping have been identified as factors that may lead to
dissatisfaction. A review by Baert et al identified catastrophic thinking and
poor coping capabilities to predict more pain after TKA, whereas evidence on
the impact on knee function remains conflicting in nature. Most studies assess
this influence only 1 year after surgery, with only the study by Brander et al
prolonging the follow-up to 5 years. Brander et al found depression to still be
associated with outcomes 5 years after TKA and reported significant
improvements after the 1 year follow-up mark in the dissatisfied population.
Whether pain catastrophising remains a significant predictor of dissatisfaction
at long-term follow-up remains to be elucidated.
To accommodate this dissatisfied population and improve durability of implants
even more, several knee systems have been developed over the years. One of the
newest models is the ATTUNE knee system (DePuy, Warsaw, Indiana, USA), first
implanted in 2011 and widely available since 2013. One of the landmark features
is a gradually reducing radius in the geometry of the femoral component, more
closely mimicking the anatomical patellofemoral joint and facilitating more
natural femoral rollback during flexion. Comparisons of the cemented ATTUNE
with previous knee systems show promising results in terms of patellofemoral
outcomes, but fail to demonstrate definitive superiority in terms of all
patient reported outcomes. Clinical superiority of the ATTUNE tends to abate
with longer follow-up, implicating a possible superiority in the short-term
recovery and return to activities. There is no follow-up study reporting the
results of the uncemented ATTUNE. Moreover, all previously cited studies report
better patellofemoral outcomes with patellar resurfacing, making it still
unclear whether the implicated superior design changes of the femoral component
hold ground without patellar resurfacing.
It is of utmost importance to assess the metric properties of a questionnaires
when investigating an outcome. A recent study
showed the University of California Los Angeles (UCLA) activity scale to be the
best measure for assessment of activity outcome
after arthroplasty surgery. To our knowledge, no validated Dutch version of the
UCLA activity scale has been made.
Study objective
The primary objective is to report survivorship, complications and patient
reported outcome measures associated with the uncemented ATTUNE rotating
platform knee system. Secondary objectives are (1) evaluate patient reported
(patellofemoral) outcomes (2) assess return to work and sport after TKA and (3)
analyse psychologic factors (such as pain catastrophising and coping) and the
impact on dissatisfaction following TKA.
Study design
Multi-center prospective cohort study.
Intervention
The only difference with standard care is uncemented fixation of the
prosthesis. Patients normally receive a cemented prosthesis
in our institution (Spaarne Gasthuis), in other participating institutions
uncemented fixation can be standard of care.
Study burden and risks
Overall, we believe the additional risks involved with the current study are
minimal and limited to the extra radiation dosage for long-leg radiography,
which is standard of care in many other institutions. The implant has been
shown to migrate well below threshold after 2 years using RSA (which is a
predictor for long-term fixation). Additional questionnaires and follow-up
visits might be an inconvenience for some patients, but pose no extra risk and
some patients may even like the extra attention and care given.
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Listed location countries
Age
Inclusion criteria
End-stage osteoarthritis of the knee warranting joint replacement therapy.
Capability and willingness to sign informed consent and comply with follow-up
procedures.
Age between 21-90 years.
Capable enough in Dutch or English to be able to understand study procedures
Exclusion criteria
An a-priori risk for a posterior-stabilized knee system (history of
patellectomy or preoperative flexion limitation <90 degrees)
Unable or unwilling to sign informed consent and comply with follow-up
Indication for primary revision arthroplasty
Absolute indication for cemented fixation (decreased bone stock/quality of
spongiosa)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71274.029.19 |