NCT05599776 The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR
| NCT ID | NCT05599776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Coxa, Hospital for Joint Replacement |
| Condition | Osteo Arthritis Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 338 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 338 participants in total. It began in 2022-11-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Aleksi Reito, MD, PhD
PRINCIPAL INVESTIGATOR
Coxa, Hospital for Joint Replacement
Frequently Asked Questions
Who can join the NCT05599776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05599776 currently recruiting?
Yes, NCT05599776 is actively recruiting participants. Contact the research team at aleksi.reito@pshp.fi for enrollment information.
Where is the NCT05599776 trial being conducted?
This trial is being conducted at Tampere, Finland.
Who is sponsoring the NCT05599776 clinical trial?
NCT05599776 is sponsored by Coxa, Hospital for Joint Replacement. The principal investigator is Aleksi Reito, MD, PhD at Coxa, Hospital for Joint Replacement. The trial plans to enroll 338 participants.