The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR
ConditionOsteo Arthritis Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCoxa, Hospital for Joint Replacement
About this trial
The goal of this randomized controlled trial is to learn about the effect of a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor patient reported outcome after a primary total knee replacement.
The main question it aims to answer is whether a wearable activity tracker assisted physiotherapeutic intervention and remote monitoring may help to decrease the number of the poor patient reported post-operative outcome 12 months after a primary total knee replacement.
Participants will receive standard postoperative care which includes physiotherapy appointments 4 weeks and 3 months after the surgery and they will use smart rings (Oura ring) 3 months postoperatively. Patients will be remotely monitored to follow their recovery from total knee replacement surgery: the study group physiotherapists will follow the patients' activity and sleep and if necessary, make a contact with patient if there seems to low activity indicating difficulties with recovering from the surgery.
Researchers will compare the intervention group to a group of participants who will receive only standard postoperative care with physiotherapy appointments 4 weeks and 3 months, to see if the use of the Oura ring may decrease the number of participants with poor patient reported post-operative outcome after total knee replacement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing primary TKA for primary osteoarthritis.
Patients able to consent and willing to comply with the study protocol.
Patients aged 18 to 70 years
Patients is able to use a smartphone and a smart ring.
Disqualifiers
Patients unwilling to provide informed consent
>15 degrees varus or valgus, or > 15 degrees fixed flexion deformity
Physical, emotional, or neurological conditions that would compromise the patient, e.g., poor compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions, such as Parkinson, MS, etc.)
Patients unable to attend the study physiotherapy appointments at the outpatient clinic.
Trial design
Design model
Parallel
Treatments tested in this trial
Smart ring assisted physiotherapeutic intervention
Other interventionthe effect of a smart ring (Oura), a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor outcome measured on patient reported post-operative outcome (Oxford Knee Score) 12 months after a primary total knee replacement.
Treatment groups
338 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the proportion of patients with poor postoperative outcome
Time frame
12 months after total knee replacement surgerySecondary outcomes
1
homogeneity of variance in the Oxford Knee Score
Time frame
12 months after the surgery2
Oxford Knee Score
difference between groups
Time frame
3 months after the surgery3
Oxford Knee Score
difference between groups
Time frame
6 months after the surgery4
Oxford Knee Score
difference between groups
Time frame
12 months after the surgeryOther outcomes
1
the visits to the emergency department
Time frame
during the 12-month follow-up after surgery2
the readmissions to Coxa Hospital
Time frame
during the 12-month follow-up after surgery3
The rate of manipulation under anesthesia
Time frame
during the 12-month follow-up after surgery4
complications
Time frame
during the 12-month follow-up after surgerySponsors and contacts
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Source ClinicalTrials.gov