Osteo Arthritis KneeSmarTKRingNCT05599776
The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR
A study testing Smart ring assisted physiotherapeutic intervention in people with Osteo Arthritis Knee, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Smart ring assisted physiotherapeutic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteFinland
- Study dates
- 2 Nov 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Coxa Hospital for Joint Replacement
Tampere, Pirkanmaa, 33520
Elisa Leinonen, RC, +358 3311 78030, elisa.leinonen@coxa.fi
About this study
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
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.
Read more
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
- Being tested
- Smart ring assisted physiotherapeutic intervention
- Keywords
- total knee replacement, wearable activity tracker, smart ring, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart ring assisted physiotherapeutic interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Smart ring assisted physiotherapeutic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with poor postoperative outcome
Measured: 12 months after total knee replacement surgery
Secondary outcomes (22)
homogeneity of variance in the Oxford Knee Score
Measured: 12 months after the surgery
Oxford Knee Score
difference between groups
Measured: 3 months after the surgery
Oxford Knee Score
difference between groups
Measured: 6 months after the surgery
Oxford Knee Score
difference between groups
Measured: 12 months after the surgery
EQ-5D-5L
difference in quality of life
Measured: 3 months after the surgery
EQ-5D-5L
difference in quality of life
Measured: 6 months after the surgery
EQ-5D-5L
difference in quality of life
Measured: 12 months after the surgery
Forgotten Joint Score 12 (FJS-12)
Measured: 3 months after the surgery
Forgotten Joint Score 12 (FJS-12)
Measured: 6 months after the surgery
Forgotten Joint Score 12 (FJS-12)
Measured: 12 months after the surgery
pain at rest using the visual analoque (VAS scale)
Measured: 3 months after surgery
pain at rest using the visual analoque (VAS scale)
Measured: 6 months after surgery
pain at rest using the visual analoque (VAS scale)
Measured: 12 months after surgery
pain while walking using the visual analoque (VAS scale)
Measured: 3 months after surgery
pain while walking using the visual analoque (VAS scale)
Measured: 6 months after surgery
pain while walking using the visual analoque (VAS scale)
Measured: 12 months after surgery
active knee range of motion
Measured: 3 months after surgery
active knee range of motion
Measured: 12 months after surgery
passive knee range of motion
Measured: 3 months after surgery
passive knee range of motion
Measured: 12 months after surgery
The patient satisfaction VAS
Measured: 12 months after surgery
patient accepted symptom state questions
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start2 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksi Reito, MD, PhD, Principal investigator, Coxa, Hospital for Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599776
- Sponsor's protocol ID
- R22078
- Acronym
- SmarTKRing
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share IPD against well-planned research protocol.
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.
PubMed 40379331
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05599776
- Acronym / sponsor ID
- SmarTKRing / R22078
- Conditions
- Osteo Arthritis Knee
- Keywords
- total knee replacement, wearable activity tracker, smart ring, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Smart ring assisted physiotherapeutic interventionThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart ring assisted physiotherapeutic interventionthe 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. | Other | Intervention group |
Primary outcome
the proportion of patients with poor postoperative outcome
Time frame: 12 months after total knee replacement surgery
22 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 40379331Hautala 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.
- Individual participant dataSharing planned: Undecided. We will share IPD against well-planned research protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksi Reito, MD, PhD principal investigator
Coxa, Hospital for Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart ring assisted physiotherapeutic intervention in people with Osteo Arthritis Knee, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksi Reito, MD, PhD (+358444729631, aleksi.reito@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients with poor postoperative outcome (time frame: 12 months after total knee replacement surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05599776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.