The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR (SmarTKRing)

Coxa, Hospital for Joint Replacement

Status: Enrolling

Conditions: Osteo Arthritis Knee

Treatments: Other: Smart ring assisted physiotherapeutic intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05599776

R22078

Details and patient eligibility

About

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.

Enrollment: 338 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

Control group

No Intervention group

Description:

The control group of this trial will receive standard postoperative care which includes physiotherapy appointments 4 weeks and 3 months after the surgery. The 4-week physiotherapy appointment will be at local health center, occupational health clinic or in private physiotherapy clinic and patients are instructed to book the appointments independently according to the standard of care in Coxa Hospital. The 3-month physiotherapy appointment in Coxa Hospital will be carried out by physiotherapists who are dedicated to research projects at Coxa outpatient clinic.

Intervention group

Experimental group

Description:

The patients in the intervention group will receive standard physiotherapy care but patients also use smart rings (Oura ring) 3 months postoperatively. Patients will be remotely monitored to follow their recovery from TKR 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. If there is a constantly decreasing trends in these parameters or patient improvement plateaus, patient is contacted and their status is evaluated by telephone. Based on the information from this contact, the patients may be asked to visit the physiotherapist at the outpatient clinic to assess the situation, and also anesthetist may be consulted on the pain medication. Data collected with the Oura ring will also be used in physiotherapy appointments as a part of therapeutic treatment and guidance.

Treatment:

Other: Smart ring assisted physiotherapeutic intervention