Osteo Arthritis Knee
Conditions
Keywords
total knee replacement, wearable activity tracker, smart ring, physiotherapy
Brief summary
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.
Interventions
OTHERSmart ring assisted physiotherapeutic intervention
the 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.
Sponsors
Coxa, Hospital for Joint Replacement
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study design is a 2 arm, 1:1 randomized, controlled, single-center trial adhering to Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) guidelines. The study will be carried out at Coxa Hospital for Joint Replacement (Tampere, Finland), a university-affiliated publicly funded orthopaedic hospital specializing in joint replacement surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Patients unable to wear Oura ring (example in case of OA or rheumatoid arthritis in the finger joints). * Patients with cardiac arrhythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with poor postoperative outcome | 12 months after total knee replacement surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forgotten Joint Score 12 (FJS-12) | 3 months after the surgery | — |
| active knee range of motion | 3 months after surgery | — |
| passive knee range of motion | 3 months after surgery | — |
| The patient satisfaction VAS | 12 months after surgery | — |
| patient accepted symptom state questions | 12 months after surgery | — |
| homogeneity of variance in the Oxford Knee Score | 12 months after the surgery | — |
| Oxford Knee Score | 3 months after the surgery | difference between groups |
| EQ-5D-5L | 3 months after the surgery | difference in quality of life |
| pain at rest using the visual analoque (VAS scale) | 3 months after surgery | — |
| pain while walking using the visual analoque (VAS scale) | 3 months after surgery | — |
Other
| Measure | Time frame |
|---|---|
| The rate of manipulation under anesthesia | during the 12-month follow-up after surgery |
| complications | during the 12-month follow-up after surgery |
| the readmissions to Coxa Hospital | during the 12-month follow-up after surgery |
| the visits to the emergency department | during the 12-month follow-up after surgery |
Countries
Finland
Contacts
Primary ContactAleksi Reito, MD, PhD
Backup ContactElisa Leinonen, RN
Outcome results
None listed