Clinical trial NCT05599776: The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: total knee replacement
wearable activity tracker
smart ring
physiotherapy
Lead sponsor: Coxa, Hospital for Joint Replacement
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: the proportion of patients with poor postoperative outcome
timeFrame: 12 months after total knee replacement surgery
Secondary outcomes:
measure: homogeneity of variance in the Oxford Knee Score
timeFrame: 12 months after the surgery
measure: Oxford Knee Score
timeFrame: 3 months after the surgery
measure: Oxford Knee Score
timeFrame: 6 months after the surgery
measure: Oxford Knee Score
timeFrame: 12 months after the surgery
measure: EQ-5D-5L
timeFrame: 3 months after the surgery
measure: EQ-5D-5L
timeFrame: 6 months after the surgery
measure: EQ-5D-5L
timeFrame: 12 months after the surgery
measure: Forgotten Joint Score 12 (FJS-12)
timeFrame: 3 months after the surgery
measure: Forgotten Joint Score 12 (FJS-12)
timeFrame: 6 months after the surgery
measure: Forgotten Joint Score 12 (FJS-12)
timeFrame: 12 months after the surgery
measure: pain at rest using the visual analoque (VAS scale)
timeFrame: 3 months after surgery
measure: pain at rest using the visual analoque (VAS scale)
timeFrame: 6 months after surgery
measure: pain at rest using the visual analoque (VAS scale)
timeFrame: 12 months after surgery
measure: pain while walking using the visual analoque (VAS scale)
timeFrame: 3 months after surgery
measure: pain while walking using the visual analoque (VAS scale)
timeFrame: 6 months after surgery
measure: pain while walking using the visual analoque (VAS scale)
timeFrame: 12 months after surgery
measure: active knee range of motion
timeFrame: 3 months after surgery
measure: active knee range of motion
timeFrame: 12 months after surgery
measure: passive knee range of motion
timeFrame: 3 months after surgery
measure: passive knee range of motion
timeFrame: 12 months after surgery
measure: The patient satisfaction VAS
timeFrame: 12 months after surgery
measure: patient accepted symptom state questions
timeFrame: 12 months after surgery
Other outcomes:
measure: the visits to the emergency department
timeFrame: during the 12-month follow-up after surgery
measure: the readmissions to Coxa Hospital
timeFrame: during the 12-month follow-up after surgery
measure: The rate of manipulation under anesthesia
timeFrame: during the 12-month follow-up after surgery
measure: complications
timeFrame: during the 12-month follow-up after surgery
Locations:
city: Tampere
country: Finland
facility: Coxa Hospital for Joint Replacement
state: Pirkanmaa
Study officials:
affiliation: Coxa, Hospital for Joint Replacement
name: Aleksi Reito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: