An interventional study of Smart ring assisted physiotherapeutic intervention in Osteo Arthritis Knee, sponsored by Coxa, Hospital for Joint Replacement. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by Coxa, Hospital for Joint Replacement · Not applicable, Interventional, and Treatment
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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.
Coxa, Hospital for Joint Replacement is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
the proportion of patients with poor postoperative outcome
Time frame: 12 months after total knee replacement surgery
homogeneity of variance in the Oxford Knee Score
Time frame: 12 months after the surgery
Oxford Knee Score
difference between groups
Time frame: 3 months after the surgery
Oxford Knee Score
difference between groups
Time frame: 6 months after the surgery
Oxford Knee Score
difference between groups
Time frame: 12 months after the surgery
EQ-5D-5L
difference in quality of life
Time frame: 3 months after the surgery
EQ-5D-5L
difference in quality of life
Time frame: 6 months after the surgery
EQ-5D-5L
difference in quality of life
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
pain at rest using the visual analoque (VAS scale)
Time frame: 12 months after surgery
pain while walking using the visual analoque (VAS scale)
Time frame: 3 months after surgery
pain while walking using the visual analoque (VAS scale)
Time frame: 6 months after surgery
pain while walking using the visual analoque (VAS scale)
Time frame: 12 months after surgery
active knee range of motion
Time frame: 3 months after surgery
active knee range of motion
Time frame: 12 months after surgery
passive knee range of motion
Time frame: 3 months after surgery
passive knee range of motion
Time frame: 12 months after surgery
The patient satisfaction VAS
Time frame: 12 months after surgery
patient accepted symptom state questions
Time frame: 12 months after surgery
the visits to the emergency department
Time frame: during the 12-month follow-up after surgery
the readmissions to Coxa Hospital
Time frame: during the 12-month follow-up after surgery
The rate of manipulation under anesthesia
Time frame: during the 12-month follow-up after surgery
complications
Time frame: during the 12-month follow-up after surgery
Plan to share: Undecided — We will share IPD against well-planned research protocol.
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2026, 49 months after the start.
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Coxa, Hospital for Joint Replacement