Background:
Worldwide over a million patients receive a TKA or UKA each year and in Denmark more than
10,000 TKA and UKA's are performed annually, and the lifetime risk of symptomatic
osteoarthritis (OA) of the knees are 45%. Despite being considered a successful
intervention, 15-25% of patients following TKA are not satisfied with their output, which
to some degree may be associated with reduced daily physical activity (PA). Few
scientific studies have examined how daily PA is affected by TKA and how it might affect
rehabilitation. It is unknown if a focus on increased PA in everyday life after return
from hospital might improve rehabilitation and patient satisfaction. The current study
addresses this 'gap' in science with high-level clinical evidence, to investigate if a
novel technology on motivational feed-back regarding PA can be introduced to assist
patients with a better rehabilitation following TKA or UKA.
Aim:
The aim of this randomized controlled trial (RCT) nested in a prospective cohort is to
investigate whether PA following TKA or UKA can be optimized by the use of an activity
tracking device including motivational feedback in comparison with activity tracking
without feedback. Furthermore, a prospective cohort will investigate the predictive value
of PA level prior to TKA/UKA for the post-surgical length of stay, return to work, and
quality of life.
Trial design overview:
Design:
Randomized, blinded, two-arm, multi center trial. 150 patients scheduled for TKA or UKA
will be recruited through Odense University Hospital (Svendborg and Odense) and Vejle
Hospital. Patients will be randomized to 12 weeks of activity tracking and motivational
feed-back by gamification for patient self-mobilization (Intervention group) or
'care-as-usual' including activity tracking without motivational feed-back (control
group).
Patients that are not eligible and/or willing to participate in the RCT study will be
offered to participate in a prospective non-interventional cohort study where the main
outcome are self-reported disability, generel health, return to work, pain medication,
overall experience with TKA or UKA.
SENS Motion:
SENS Motion (SENS Innovation ApS, Copenhagen, Denmark) is a wireless medical
accelerometer for collecting objectively PA data. SENS Motion has developed a patient app
with gamification/motivational feed-back to enhance PA. SENS Motion is CE marked as a
medical device. SENS Motion has no right to unpublished study data and is neither
financially nor personally involved in this trial. None in the study group is related to
SENS Motion.
Blinding:
The primary investigator will be blinded to allocation and will not participate in
randomization of patients. The statistical analysis will be performed on allocation codes
only and thus the data analysts will be blinded in relation to intervention allocation.
Blinding to intervention of patients, surgeon, and nurses (healthcare providers) will not
be possible due to the nature of the intervention.
Randomizing and database:
Randomization is performed internet-based using REDCap Randomize, allocated 1:1. The
randomization itself takes place right after the surgery. The randomization is performed
as a block randomization in blocks of 2, 4 and 6. No stratifications are applied to the
randomization, and the primary investigator is blinded regarding the permuted blocking
strategy. A data manager, with no clinical involvement in the trial, prepares the
randomization sequence. The allocation is concealed in a password-protected computer
file.
Compliance:
Patients in the control group will have the app installed on their smartphones without
motivational feedback, solely for transferring data from the activity tracker. To prevent
data loss, weekly SMS messages will remind both intervention and control groups to open
their SENS app during the week. No standard for adherence in app interventions has been
established previously. The implementation aims for a 70% adherence rate, indicating that
the intervention group will interact with the app and obtain motivational feedback for 5
out of 7 days weekly.
All patients will receive written information on how to attach the sensor, use the app
(without a tablet), and use the tablet with motivational feedback. Moreover, all patients
will receive a link to a YouTube video presenting the project and providing instructions
on how to use the equipment.
Time points Assessment will be performed at baseline two weeks prior to surgery and
randomization, following the intervention (14 weeks post baseline) (the primary endpoint)
and a long term follow-up at 12 months post baseline.
Sample size:
Sample size is estimated using total accelerometer counts per day from a previous
publication on TKA patients. Between-group difference in change score of 50.500 activity
counts per day representing ≈ 1/3 standard deviation and a change of ≈17% is considered
clinically relevant. To achieve a statistical power of 80% (β=0.80), using a standard
deviation of 101.000 counts per day pre- and post-intervention, and allowing the
detection of statistically significant differences at an α level of 0.05 (two-tailed
testing), a sample size of n = 62 is estimated for each group. Allowing for dropout a
recruitment of 150 patients (in total) is planned.
Main comparative analyses between groups will be performed by using an intention-to-treat
analysis. Between-group mean differences and 95% confidence intervals will be estimated
with a general linear model in which the patients baseline score is entered as a
covariate and adjusted for potential baseline differences (age, sex, BMI). In addition to
the intention-to-treat analysis, a per-protocol analysis will be also be conducted.
Ethics:
The study has been submitted to the regional Committee for Medical Research Ethics, which
has assessed the project as "not subject to notification", Project-ID: S-20222000 - 171.
Finally, The Danish Medicines Agency has declared no need for further permission to carry
out the study.
Qualitative study:
A qualitative study using iterations where patients and healthcare professionals through
interviews provided input for improvements of the current technology was initiated to
tailor the technological maturation of the SENS App for the current patient group.
Evaluation and patient involvement will be based on interviews of ten patients. Feed-back
from the focus group will be implemented in an updated app-version. The first iteration
was in augus t2021, the second was in feburary 2023, the last iteration is planed in
september 2023.