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The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR (SmarTKRing)

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Smart ring assisted physiotherapeutic intervention
Sponsored by
Coxa, Hospital for Joint Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring total knee replacement, wearable activity tracker, smart ring, physiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Coxa Hospital for Joint ReplacementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the proportion of patients with poor postoperative outcome

Secondary Outcome Measures

homogeneity of variance in the Oxford Knee Score
Oxford Knee Score
difference between groups
Oxford Knee Score
difference between groups
Oxford Knee Score
difference between groups
EQ-5D-5L
difference in quality of life
EQ-5D-5L
difference in quality of life
EQ-5D-5L
difference in quality of life
Forgotten Joint Score 12 (FJS-12)
Forgotten Joint Score 12 (FJS-12)
Forgotten Joint Score 12 (FJS-12)
pain at rest using the visual analoque (VAS scale)
pain at rest using the visual analoque (VAS scale)
pain at rest using the visual analoque (VAS scale)
pain while walking using the visual analoque (VAS scale)
pain while walking using the visual analoque (VAS scale)
pain while walking using the visual analoque (VAS scale)
active knee range of motion
active knee range of motion
passive knee range of motion
passive knee range of motion
The patient satisfaction VAS
patient accepted symptom state questions

Full Information

First Posted
October 26, 2022
Last Updated
November 9, 2022
Sponsor
Coxa, Hospital for Joint Replacement
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1. Study Identification

Unique Protocol Identification Number
NCT05599776
Brief Title
The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coxa, Hospital for Joint Replacement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
total knee replacement, wearable activity tracker, smart ring, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Smart ring assisted physiotherapeutic intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of patients with poor postoperative outcome
Time Frame
12 months after total knee replacement surgery
Secondary Outcome Measure Information:
Title
homogeneity of variance in the Oxford Knee Score
Time Frame
12 months after the surgery
Title
Oxford Knee Score
Description
difference between groups
Time Frame
3 months after the surgery
Title
Oxford Knee Score
Description
difference between groups
Time Frame
6 months after the surgery
Title
Oxford Knee Score
Description
difference between groups
Time Frame
12 months after the surgery
Title
EQ-5D-5L
Description
difference in quality of life
Time Frame
3 months after the surgery
Title
EQ-5D-5L
Description
difference in quality of life
Time Frame
6 months after the surgery
Title
EQ-5D-5L
Description
difference in quality of life
Time Frame
12 months after the surgery
Title
Forgotten Joint Score 12 (FJS-12)
Time Frame
3 months after the surgery
Title
Forgotten Joint Score 12 (FJS-12)
Time Frame
6 months after the surgery
Title
Forgotten Joint Score 12 (FJS-12)
Time Frame
12 months after the surgery
Title
pain at rest using the visual analoque (VAS scale)
Time Frame
3 months after surgery
Title
pain at rest using the visual analoque (VAS scale)
Time Frame
6 months after surgery
Title
pain at rest using the visual analoque (VAS scale)
Time Frame
12 months after surgery
Title
pain while walking using the visual analoque (VAS scale)
Time Frame
3 months after surgery
Title
pain while walking using the visual analoque (VAS scale)
Time Frame
6 months after surgery
Title
pain while walking using the visual analoque (VAS scale)
Time Frame
12 months after surgery
Title
active knee range of motion
Time Frame
3 months after surgery
Title
active knee range of motion
Time Frame
12 months after surgery
Title
passive knee range of motion
Time Frame
3 months after surgery
Title
passive knee range of motion
Time Frame
12 months after surgery
Title
The patient satisfaction VAS
Time Frame
12 months after surgery
Title
patient accepted symptom state questions
Time Frame
12 months after surgery
Other Pre-specified Outcome Measures:
Title
the visits to the emergency department
Time Frame
during the 12-month follow-up after surgery
Title
the readmissions to Coxa Hospital
Time Frame
during the 12-month follow-up after surgery
Title
The rate of manipulation under anesthesia
Time Frame
during the 12-month follow-up after surgery
Title
complications
Time Frame
during the 12-month follow-up after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksi Reito, MD, PhD
Phone
+358444729631
Email
aleksi.reito@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa Leinonen, RN
Phone
+358331178030
Email
elisa.leinonen@coxa.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, MD, PhD
Organizational Affiliation
Coxa, Hospital for Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coxa Hospital for Joint Replacement
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Leinonen, RC
Phone
+358 3311 78030
Email
elisa.leinonen@coxa.fi

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will share IPD against well-planned research protocol.

Learn more about this trial

The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

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