The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

NCT ID: NCT05599776

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2027-12-31

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type: EXPERIMENTAL

Smart ring assisted physiotherapeutic intervention

Intervention Type: OTHER

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.

Interventions

Smart 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coxa, Hospital for Joint Replacement

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksi Reito, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Coxa, Hospital for Joint Replacement

Locations

Coxa Hospital for Joint Replacement

Tampere, Pirkanmaa, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Aleksi Reito, MD, PhD

Role: CONTACT

aleksi.reito@pshp.fi

+358444729631

Elisa Leinonen, RN

Role: CONTACT

elisa.leinonen@coxa.fi

+358331178030

Facility Contacts

Elisa Leinonen, RC

Role: primary

elisa.leinonen@coxa.fi

+358 3311 78030

References

Hautala J, Koriseva L, Reito A, Mattila V, Eskelinen A. Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial. BMJ Open. 2025 May 15;15(5):e091956. doi: 10.1136/bmjopen-2024-091956.

Reference Type: DERIVED

PMID: 40379331 (View on PubMed)

Other Identifiers

R22078

Identifier Type: -

Identifier Source: org_study_id