The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

Osteo Arthritis Knee Clinical Trial

— SmarTKRing  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599776
• Other study ID #: R22078
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 2027

Study information

• Verified date: November 2022
• Source: Coxa, Hospital for Joint Replacement
• Contact: Aleksi Reito, MD, PhD
• Phone: +358444729631
• Email: aleksi.reito[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Finland	Coxa Hospital for Joint Replacement	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Coxa, Hospital for Joint Replacement

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the visits to the emergency department		during the 12-month follow-up after surgery
Other	the readmissions to Coxa Hospital		during the 12-month follow-up after surgery
Other	The rate of manipulation under anesthesia		during the 12-month follow-up after surgery
Other	complications		during the 12-month follow-up after surgery
Primary	the proportion of patients with poor postoperative outcome		12 months after total knee replacement surgery
Secondary	homogeneity of variance in the Oxford Knee Score		12 months after the surgery
Secondary	Oxford Knee Score	difference between groups	3 months after the surgery
Secondary	Oxford Knee Score	difference between groups	6 months after the surgery
Secondary	Oxford Knee Score	difference between groups	12 months after the surgery
Secondary	EQ-5D-5L	difference in quality of life	3 months after the surgery
Secondary	EQ-5D-5L	difference in quality of life	6 months after the surgery
Secondary	EQ-5D-5L	difference in quality of life	12 months after the surgery
Secondary	Forgotten Joint Score 12 (FJS-12)		3 months after the surgery
Secondary	Forgotten Joint Score 12 (FJS-12)		6 months after the surgery
Secondary	Forgotten Joint Score 12 (FJS-12)		12 months after the surgery
Secondary	pain at rest using the visual analoque (VAS scale)		3 months after surgery
Secondary	pain at rest using the visual analoque (VAS scale)		6 months after surgery
Secondary	pain at rest using the visual analoque (VAS scale)		12 months after surgery
Secondary	pain while walking using the visual analoque (VAS scale)		3 months after surgery
Secondary	pain while walking using the visual analoque (VAS scale)		6 months after surgery
Secondary	pain while walking using the visual analoque (VAS scale)		12 months after surgery
Secondary	active knee range of motion		3 months after surgery
Secondary	active knee range of motion		12 months after surgery
Secondary	passive knee range of motion		3 months after surgery
Secondary	passive knee range of motion		12 months after surgery
Secondary	The patient satisfaction VAS		12 months after surgery
Secondary	patient accepted symptom state questions		12 months after surgery