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Recruiting NCT05599776

The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

No phase Interventional Osteo Arthritis Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smart ring assisted physiotherapeutic intervention.
Who it may be relevant to
Registry conditions: Osteo Arthritis Knee. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • the proportion of patients with poor postoperative outcome [Time frame: 12 months after total knee replacement surgery]
Secondary outcome measures (12)
  • homogeneity of variance in the Oxford Knee Score [Time frame: 12 months after the surgery]
  • Oxford Knee Score [Time frame: 3 months after the surgery]
  • Oxford Knee Score [Time frame: 6 months after the surgery]
  • Oxford Knee Score [Time frame: 12 months after the surgery]
  • EQ-5D-5L [Time frame: 3 months after the surgery]
  • EQ-5D-5L [Time frame: 6 months after the surgery]
  • EQ-5D-5L [Time frame: 12 months after the surgery]
  • Forgotten Joint Score 12 (FJS-12) [Time frame: 3 months after the surgery]
  • Forgotten Joint Score 12 (FJS-12) [Time frame: 6 months after the surgery]
  • Forgotten Joint Score 12 (FJS-12) [Time frame: 12 months after the surgery]
  • pain at rest using the visual analoque (VAS scale) [Time frame: 3 months after surgery]
  • pain at rest using the visual analoque (VAS scale) [Time frame: 6 months after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Coxa Hospital for Joint Replacement — Tampere

Publications

  • 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

Identifiers

NCT: NCT05599776 · R22078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗