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

The Effect of Smart Ring Assisted Physiotherapeutic Intervention on the Risk of Poor Outcome 12 Months After a Total Knee Replacement: a Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Other: Smart ring assisted physiotherapeutic intervention

• Study Type: Interventional
• Enrollment (Anticipated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksi Reito, MD, PhD; Phone Number: +358444729631; Email: aleksi.reito@pshp.fi
• Study Contact Backup: Name: Elisa Leinonen, RN; Phone Number: +358331178030; Email: elisa.leinonen@coxa.fi

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Recruiting
      • Coxa Hospital for Joint Replacement
      • Contact: Elisa Leinonen, RC; Phone Number: +358 3311 78030; Email: elisa.leinonen@coxa.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the proportion of patients with poor postoperative outcome	12 months after total knee replacement surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
homogeneity of variance in the Oxford Knee Score		12 months after the surgery
Oxford Knee Score	difference between groups	3 months after the surgery
Oxford Knee Score	difference between groups	6 months after the surgery
Oxford Knee Score	difference between groups	12 months after the surgery
EQ-5D-5L	difference in quality of life	3 months after the surgery
EQ-5D-5L	difference in quality of life	6 months after the surgery
EQ-5D-5L	difference in quality of life	12 months after the surgery
Forgotten Joint Score 12 (FJS-12)		3 months after the surgery
Forgotten Joint Score 12 (FJS-12)		6 months after the surgery
Forgotten Joint Score 12 (FJS-12)		12 months after the surgery
pain at rest using the visual analoque (VAS scale)		3 months after surgery
pain at rest using the visual analoque (VAS scale)		6 months after surgery
pain at rest using the visual analoque (VAS scale)		12 months after surgery
pain while walking using the visual analoque (VAS scale)		3 months after surgery
pain while walking using the visual analoque (VAS scale)		6 months after surgery
pain while walking using the visual analoque (VAS scale)		12 months after surgery
active knee range of motion		3 months after surgery
active knee range of motion		12 months after surgery
passive knee range of motion		3 months after surgery
passive knee range of motion		12 months after surgery
The patient satisfaction VAS		12 months after surgery
patient accepted symptom state questions		12 months after surgery

Other Outcome Measures

Outcome Measure	Time Frame
the visits to the emergency department	during the 12-month follow-up after surgery
the readmissions to Coxa Hospital	during the 12-month follow-up after surgery
The rate of manipulation under anesthesia	during the 12-month follow-up after surgery
complications	during the 12-month follow-up after surgery

Collaborators and Investigators

• Sponsor: Coxa, Hospital for Joint Replacement
• Investigators: Principal Investigator: Aleksi Reito, MD, PhD, Coxa, Hospital for Joint Replacement

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: total knee replacement; physiotherapy; wearable activity tracker; smart ring
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: R22078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will share IPD against well-planned research protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No