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NCT Number: NCT05599776

The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coxa Hospital for Joint Replacement

Tampere, Pirkanmaa, 33520, Finland

Location status: Recruiting

Location contact

Elisa Leinonen, RC

CONTACT

[email protected]

+358 3311 78030

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. the proportion of patients with poor postoperative outcome

    Time frame: 12 months after total knee replacement surgery

Secondary outcomes

  1. homogeneity of variance in the Oxford Knee Score

    Time frame: 12 months after the surgery

  2. Oxford Knee Score

    Time frame: 3 months after the surgery

    difference between groups

  3. Oxford Knee Score

    Time frame: 6 months after the surgery

    difference between groups

  4. Oxford Knee Score

    Time frame: 12 months after the surgery

    difference between groups

  5. EQ-5D-5L

    Time frame: 3 months after the surgery

    difference in quality of life

  6. EQ-5D-5L

    Time frame: 6 months after the surgery

    difference in quality of life

  7. EQ-5D-5L

    Time frame: 12 months after the surgery

    difference in quality of life

  8. Forgotten Joint Score 12 (FJS-12)

    Time frame: 3 months after the surgery

  9. Forgotten Joint Score 12 (FJS-12)

    Time frame: 6 months after the surgery

  10. Forgotten Joint Score 12 (FJS-12)

    Time frame: 12 months after the surgery

  11. pain at rest using the visual analoque (VAS scale)

    Time frame: 3 months after surgery

  12. pain at rest using the visual analoque (VAS scale)

    Time frame: 6 months after surgery

  13. pain at rest using the visual analoque (VAS scale)

    Time frame: 12 months after surgery

  14. pain while walking using the visual analoque (VAS scale)

    Time frame: 3 months after surgery

  15. pain while walking using the visual analoque (VAS scale)

    Time frame: 6 months after surgery

  16. pain while walking using the visual analoque (VAS scale)

    Time frame: 12 months after surgery

  17. active knee range of motion

    Time frame: 3 months after surgery

  18. active knee range of motion

    Time frame: 12 months after surgery

  19. passive knee range of motion

    Time frame: 3 months after surgery

  20. passive knee range of motion

    Time frame: 12 months after surgery

  21. The patient satisfaction VAS

    Time frame: 12 months after surgery

  22. patient accepted symptom state questions

    Time frame: 12 months after surgery

Other outcomes

  1. the visits to the emergency department

    Time frame: during the 12-month follow-up after surgery

  2. the readmissions to Coxa Hospital

    Time frame: during the 12-month follow-up after surgery

  3. The rate of manipulation under anesthesia

    Time frame: during the 12-month follow-up after surgery

  4. complications

    Time frame: during the 12-month follow-up after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksi Reito, MD, PhD

CONTACT

[email protected]

+358444729631

Elisa Leinonen, RN

CONTACT

[email protected]

+358331178030

Sponsors and collaborators

Lead sponsor

Coxa, Hospital for Joint Replacement

Other

Registry information

Official study 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

Acronym: SmarTKRing

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 31, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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