The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

NCT05599776 | Recruiting

• 1 other identifier: R22078
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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

Keywords

total knee replacement; wearable activity tracker; smart ring; physiotherapy

Outcome Measures

Primary Outcomes (1)

• the proportion of patients with poor postoperative outcome

  12 months after total knee replacement surgery

Secondary Outcomes (22)

• homogeneity of variance in the Oxford Knee Score

  12 months after the surgery

• Oxford Knee Score

  3 months after the surgery

• Oxford Knee Score

  6 months after the surgery

• Oxford Knee Score

  12 months after the surgery

• EQ-5D-5L

  3 months after the surgery

Other Outcomes (4)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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

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

Interventions

Smart ring assisted physiotherapeutic intervention 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coxa, Hospital for Joint Replacement: lead

Study Sites (1)

Coxa Hospital for Joint Replacement

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 40379331 DERIVED

Study Officials

• Aleksi Reito, MD, PhD

  Coxa, Hospital for Joint Replacement

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksi Reito, MD, PhD

CONTACT

+358444729631; aleksi.reito@pshp.fi

Elisa Leinonen, RN

CONTACT

+358331178030; elisa.leinonen@coxa.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

FI (1)