Knee ArthritisNCT03406455
Telemedicine in Total Knee Arthroplasty Using Wearable Technology
An observational study of Knee Arthritis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Subjectivity, cost-effectiveness, and inconsistent reporting limit monitoring after total knee arthroplasty (TKA). This prospective study leverages machine learning wearable technology to remotely monitor patients before and after TKA with fidelity and reliability, without sacrificing safe triage needing increased… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of 25 patients undergoing primary TKA for osteoarthritis at our hospital will be enrolled into the study, which will receive IRB approval and be registered on ClinicalTrials.gov and RedCap. Patients will download the mobile application onto their personal smartphones (iOS) to record baseline activity and PROMs in the 2-4 weeks leading up to surgery. During the hospital admission, the knee sleeve will be fitted to the patient. The patient cohort will be followed for three months and four data points (both passive and active) will be extracted from the dashboard: PROMs, mean daily steps, ROM (particular attention to 2 weeks postoperatively), and home exercise plan (HEP) compliance.
Who may be able to join
- patients undergoing primary TKA for osteoarthritis
- patients who have an iOS smartphone and carry it with them daily
- patients who reside in a home and not a facility or rehabilitation center
- patients under the age of 80 years
- patients who preoperatively have not used any assist devices for more than a year due to the non-affected joint or other functional reasons, including back pain.
Who cannot join
- patients receiving treatment for inflammatory arthritis
- patients receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant
- patients with any other medical issues limiting mobility and function, including cardiopulmonary, gastrointestinal, and hematologic comorbidities
- patients indicated for TKA for post-traumatic or inflammatory arthritis
- patients who have ever had a periprosthetic joint infection of any joint
- patients who have a history of native septic arthritis in the operative joint
Show all 9Show fewer
- patients who were functionally immobilized or residing anywhere other than a home (nursing facility, rehabilitation centers)
- patients who preoperatively used an assist device for more than a year (i.e. cane, walker)
- patients over the age of 80 years.
Trial locations and contacts
1 site in 1 country.
About this study
Subjectivity, cost-effectiveness, and inconsistent reporting limit monitoring after total knee arthroplasty (TKA). This prospective study leverages machine learning wearable technology to remotely monitor patients before and after TKA with fidelity and reliability, without sacrificing safe triage needing increased perioperative attention. Patients will download a mobile app that pairs with a "smart" knee sleeve to (1) monitor activity via daily step count, (2) solicit patient-reported outcomes, (3) calculate max flexion, and (4) provide physical therapy compliance data. The primary objective of this study is to determine validity and acceptability of the technology; secondary objectives include perioperative benchmarking with characterization of post-operative recovery trajectories.
Read the detailed description
Monitoring of pre-operative status and post-operative recovery from elective orthopaedic surgery is critical to delivering safe, value-based care. Measurement after TKA has traditionally been accomplished through clinician in-office assessments, validated surveys, or both; subjectivity, cost-effectiveness, and inconsistent reporting limit these assessments. Leveraging now ubiquitous smartphone technology and smart wearable technology with machine learning software offers the opportunity to remotely monitor patients before and after surgery. This provides surgeons, hospitals, and stakeholders the opportunity to objectively quantify (1) patient compliance, (2) value of a given surgical procedure with unprecedented benchmarking, and, more importantly, (3) the better triage of those needing increased perioperative attention. Regardless of the orthopaedic procedure, a motion-based machine learning software application to commercial mobile and wearable technology readily and inexpensively unlocks the potential of delivering value-based care through the low maintenance acquisition of both precision, small data that may then be extrapolated to population-level revelations from big data regardless of the joint or extremity. With the rise of telemedicine, clinical validation of the technology is of mutual interest to orthopaedic patients, surgeons, administrators, payers, and policymakers.
- Conditions
- Knee Arthritis
- Keywords
- wearable, mhealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary TKA | A cohort of 25 patients undergoing primary TKA for osteoarthritis at our hospital will be enrolled into the study, which will receive IRB approval and be registered on ClinicalTrials.gov and RedCap. Patients will download the mobile application onto their personal smartphones (iOS) to record baseline activity and PROMs in the 2-4 weeks leading up to surgery. During the hospital admission, the knee sleeve will be fitted to the patient. The patient cohort will be followed for three months and four data points (both passive and active) will be extracted from the dashboard: PROMs, mean daily steps, ROM (particular attention to 2 weeks postoperatively), and home exercise plan (HEP) compliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Semi-structured interviewed
Measured: 3 months postoperative
Secondary outcomes (4)
Step Count in steps per day
Passively collect steps for TKA patients before and after surgery. This will be used for comparing pre- and post-operative improvements.
Measured: Daily, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 120 days
Maximum knee range of motion in degrees
Actively collect max extension and flexion for TKA patients before and after surgery. This will be used for comparing pre- and post-operative improvements.
Measured: Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Patient Reported Outcome Measures (linear numeric scale from 0 to 28)
Actively collect KOOS Jr., VAS pain scales. This will be used for comparing pre- and post-operative improvements.
Measured: Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Home Exercise Plan compliance
Passively collect completion of at least one home exercise per day, as reported in binary fashion (yes or no)
Measured: Daily, from day of surgery to 3 months postoperatively totaling approximately 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start2 Jul 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prem N Ramkumar, The Cleveland Clinic
- Investigators
- Annabelle Visperas, BS, Study director, IRB Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406455
- Sponsor's protocol ID
- ClevelandCF02
- Status last verified
- Jul 2019
- First submitted
- 9 Dec 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramkumar PN, Muschler GF, Spindler KP, Harris JD, McCulloch PC, Mont MA. Open mHealth Architecture: A Primer for Tomorrow's Orthopedic Surgeon and Introduction to Its Use in Lower Extremity Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1058-1062. doi: 10.1016/j.arth.2016.11.019. Epub 2016 Nov 17.
PubMed 27956125Ramkumar PN, Navarro SM, Chughtai M, La T Jr, Fisch E, Mont MA. The Patient Experience: An Analysis of Orthopedic Surgeon Quality on Physician-Rating Sites. J Arthroplasty. 2017 Sep;32(9):2905-2910. doi: 10.1016/j.arth.2017.03.053. Epub 2017 Apr 4.
PubMed 28455178Ramkumar PN, Harris JD, Noble PC. Patient-reported outcome measures after total knee arthroplasty: a systematic review. Bone Joint Res. 2015 Jul;4(7):120-7. doi: 10.1302/2046-3758.47.2000380.
PubMed 26220999
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in Total Knee Arthroplasty Using Wearable Technology
- ClinicalTrials.gov ID
- NCT03406455
- Acronym / sponsor ID
- ClevelandCF02
- Conditions
- Knee Arthritis
- Keywords
- wearable, mhealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjectivity, cost-effectiveness, and inconsistent reporting limit monitoring after total knee arthroplasty (TKA). This prospective study leverages machine learning wearable technology to remotely monitor patients before and after TKA with fidelity and reliability, without sacrificing safe triage needing increased perioperative attention. Patients will download a mobile app that pairs with a "smart" knee sleeve to (1) monitor activity via daily step count, (2) solicit patient-reported outcomes, (3) calculate max flexion, and (4) provide physical therapy compliance data. The primary objective of this study is to determine validity and acceptability of the technology; secondary objectives include perioperative benchmarking with characterization of post-operative recovery trajectories.
Detailed description
Monitoring of pre-operative status and post-operative recovery from elective orthopaedic surgery is critical to delivering safe, value-based care. Measurement after TKA has traditionally been accomplished through clinician in-office assessments, validated surveys, or both; subjectivity, cost-effectiveness, and inconsistent reporting limit these assessments. Leveraging now ubiquitous smartphone technology and smart wearable technology with machine learning software offers the opportunity to remotely monitor patients before and after surgery. This provides surgeons, hospitals, and stakeholders the opportunity to objectively quantify (1) patient compliance, (2) value of a given surgical procedure with unprecedented benchmarking, and, more importantly, (3) the better triage of those needing increased perioperative attention. Regardless of the orthopaedic procedure, a motion-based machine learning software application to commercial mobile and wearable technology readily and inexpensively unlocks the potential of delivering value-based care through the low maintenance acquisition of both precision, small data that may then be extrapolated to population-level revelations from big data regardless of the joint or extremity. With the rise of telemedicine, clinical validation of the technology is of mutual interest to orthopaedic patients, surgeons, administrators, payers, and policymakers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary TKA | – | –A cohort of 25 patients undergoing primary TKA for osteoarthritis at our hospital will be enrolled into the study, which will receive IRB approval and be registered on ClinicalTrials.gov and RedCap. Patients will download the mobile application onto their personal smartphones (iOS) to record baseline activity and PROMs in the 2-4 weeks leading up to surgery. During the hospital admission, the knee sleeve will be fitted to the patient. The patient cohort will be followed for three months and four data points (both passive and active) will be extracted from the dashboard: PROMs, mean daily steps, ROM (particular attention to 2 weeks postoperatively), and home exercise plan (HEP) compliance. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 25 patients undergoing primary TKA for osteoarthritis at our hospital will be enrolled into the study, which will receive IRB approval and be registered on ClinicalTrials.gov and RedCap. Patients will download the mobile application onto their personal smartphones (iOS) to record baseline activity and PROMs in the 2-4 weeks leading up to surgery. During the hospital admission, the knee sleeve will be fitted to the patient. The patient cohort will be followed for three months and four data points (both passive and active) will be extracted from the dashboard: PROMs, mean daily steps, ROM (particular attention to 2 weeks postoperatively), and home exercise plan (HEP) compliance.
Key inclusion criteria (5 listed)
- patients undergoing primary TKA for osteoarthritis
- patients who have an iOS smartphone and carry it with them daily
- patients who reside in a home and not a facility or rehabilitation center
- patients under the age of 80 years
- patients who preoperatively have not used any assist devices for more than a year due to the non-affected joint or other functional reasons, including back pain.
Key exclusion criteria (9 listed)
- patients receiving treatment for inflammatory arthritis
- patients receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant
- patients with any other medical issues limiting mobility and function, including cardiopulmonary, gastrointestinal, and hematologic comorbidities
- patients indicated for TKA for post-traumatic or inflammatory arthritis
- patients who have ever had a periprosthetic joint infection of any joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability
Time frame: 3 months postoperative
Semi-structured interviewed
4 secondary outcomes
Step Count in steps per day
Time frame: Daily, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 120 days
Maximum knee range of motion in degrees
Time frame: Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Patient Reported Outcome Measures (linear numeric scale from 0 to 28)
Time frame: Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Home Exercise Plan compliance
Time frame: Daily, from day of surgery to 3 months postoperatively totaling approximately 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Background: PubMed 27956125Ramkumar PN, Muschler GF, Spindler KP, Harris JD, McCulloch PC, Mont MA. Open mHealth Architecture: A Primer for Tomorrow's Orthopedic Surgeon and Introduction to Its Use in Lower Extremity Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1058-1062. doi: 10.1016/j.arth.2016.11.019. Epub 2016 Nov 17.
- Background: PubMed 28455178Ramkumar PN, Navarro SM, Chughtai M, La T Jr, Fisch E, Mont MA. The Patient Experience: An Analysis of Orthopedic Surgeon Quality on Physician-Rating Sites. J Arthroplasty. 2017 Sep;32(9):2905-2910. doi: 10.1016/j.arth.2017.03.053. Epub 2017 Apr 4.
- Background: PubMed 26220999Ramkumar PN, Harris JD, Noble PC. Patient-reported outcome measures after total knee arthroplasty: a systematic review. Bone Joint Res. 2015 Jul;4(7):120-7. doi: 10.1302/2046-3758.47.2000380.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annabelle Visperas, BS study director
IRB Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthritis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406455, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.