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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteo Arthritis Knee
- Sponsor
- Coxa, Hospital for Joint Replacement
- Enrollment
- 338
- Locations
- 1
- Primary Endpoint
- the proportion of patients with poor postoperative outcome
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
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(12 months after the surgery)
- Oxford Knee Score(12 months after the surgery)
- Forgotten Joint Score 12 (FJS-12)(12 months after the surgery)
- pain while walking using the visual analoque (VAS scale)(12 months after surgery)
- The patient satisfaction VAS(12 months after surgery)
- passive knee range of motion(12 months after surgery)
- patient accepted symptom state questions(12 months after surgery)
- EQ-5D-5L(12 months after the surgery)
- pain at rest using the visual analoque (VAS scale)(12 months after surgery)
- active knee range of motion(12 months after surgery)