The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

Coxa, Hospital for Joint Replacement338 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

338

Conditions

Osteo Arthritis Knee

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the proportion of patients with poor postoperative outcome

Time frame: 12 months after total knee replacement surgery

Secondary Outcomes

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)