The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

Not Applicable

Recruiting

• Conditions: Osteo Arthritis Knee
• Interventions: Other: Smart ring assisted physiotherapeutic intervention

• Registration Number: NCT05599776
• Lead Sponsor: Coxa, Hospital for Joint Replacement

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Status Verified: 2022-11
• Study Start: 2022-11-02
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 338

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Smart ring assisted physiotherapeutic intervention	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.

Primary Outcome Measures

Name	Time	Method
the proportion of patients with poor postoperative outcome	12 months after total knee replacement surgery

Secondary Outcome Measures

Name	Time	Method
homogeneity of variance in the Oxford Knee Score	12 months after the surgery
Oxford Knee Score	12 months after the surgery	difference between groups
Forgotten Joint Score 12 (FJS-12)	12 months after the surgery
pain while walking using the visual analoque (VAS scale)	12 months after surgery
The patient satisfaction VAS	12 months after surgery
passive knee range of motion	12 months after surgery
patient accepted symptom state questions	12 months after surgery
EQ-5D-5L	12 months after the surgery	difference in quality of life
pain at rest using the visual analoque (VAS scale)	12 months after surgery
active knee range of motion	12 months after surgery

Trial Locations

Locations (1)

Coxa Hospital for Joint Replacement; 🇫🇮 Tampere, Pirkanmaa, Finland