Total Knee ArthroplastyMEDNCT03010605
Measuring Every Day (MED) Study
A study testing Measuring Every Day Device and Physical Therapy in people with Total Knee Arthroplasty, run by The Christ Hospital at 1 site in United States.
Trial summary
Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for return to optimum function. Traditionally, adequate range of motion has been achieved by a combination of in-home and outpatient physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Measuring Every Day Device and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Aug 2018
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is able to provide written informed consent.
- Age 18 - 64 years of age
- Subject has undergone successful unilateral total knee arthroplasty for degenerative joint disease
- Subject has access to an Apple device with Bluetooth capability
- Subject is able to demonstrate the capability of setting up and using an Apple application for remote data collection and transmission
- Subject is able to demonstrate capability of correctly using the MED device
- Subject is able to comply with post-operative visits and evaluations
Who cannot join
- Subject is scheduled for an index knee revision surgery
- Subject has pre-operative flexion range of motion less than 110 degrees
- Subject has a pre-operative flexion contracture greater than 15 degrees.
- Subject has additional joint replacement surgery scheduled within the six week study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Measuring Every Day, Patient Incentive Device, as an Adjunct to Conventional Physical Therapy in the Acceleration of Flexion and Extension Capability in the Post-Operative Total Knee Arthroplasty Patient: A Prospective, Randomized Study
Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for return to optimum function. Traditionally, adequate range of motion has been achieved by a combination of in-home and outpatient physical therapy. While physical therapy is successful, it has the limitation of cost and availability. As copayments rise, patients may decide that they cannot afford physical therapy, potentially compromising the outcome of their surgery and successful return to function.
It is assumed that having an easy and fun to use, patient administered, incentive device that provides accurate, quantitative flexion and extension measurements may accelerate patient mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer is commercially available and provides objective, consistent range of motion measurements that are recorded and can be sent electronically to the clinician's office potentially enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.
Read more
Goniometry is a commonly used tool to measure and document range of motion (ROM) during clinical evaluation or a physical therapy examination. The technique is used to assess the limitations of a patient's joint and provide information to the clinician that may help determine further treatment.
The study is designed to compare range of motion measurement data for 6 weeks in patients that have been randomized to receive either traditional physical therapy or the MED device. The hypothesis is that patients who use the MED device achieve equivalent range of motion at six weeks as compared to patients participating in traditional standard of care physical therapy.
Read the detailed description
The MED is a commercially available, digital range of motion monitoring device for patients recovering from knee surgery. It displays both flexion and extension measurements and has the option of connecting to an Apple or Android device to send data to the clinician's office for review. Patients will have the capability to log on to the Measuring Every Day website with an assigned username and a password which they create. This will allow them to view their progress and send messages to the study team. Study team members will also have access to this website for review and the ability to send and receive messages. All shared files will reside on an Amazon HIPAA compliant platform.
This is a prospective, randomized, unblinded, single-center study to compare the MED device to traditional physical therapy. The study will include 46 patients who have undergone successful, unilateral total knee arthroplasty. All patients will receive a minimum of 2 physical therapy sessions prior to hospital discharge and also be instructed to flex and extend their operative knee 10 times every 15 minutes while awake as per standard of care after discharge. Patients will be randomized in a 1:1 ratio prior to discharge from the hospital to either: 1) total knee arthroplasty standard of care rehab which consists of 2 weeks of in-home physical therapy consisting of 3 sessions per week starting within 48 hours of hospital discharge, followed by 4 weeks of out-patient therapy three times weekly, or 2) ten repetitions with the MED device three times daily at 8:00am, 2:00pm and 8:00pm. Patients will transmit the 10th measurement of each time point to the clinician's office. Patients randomized to the MED device will be trained on the use of the device prior to hospital discharge.
All enrolled subjects will return to the surgeon's office at Week 2 to have their index knee range of motion measured by the PI or study coordinators with the MED device. If subjects enrolled in the MED device arm do not have a minimum flexion of 90 degrees and extension of -25 degrees, they will be considered screen failures and return to traditional physical therapy.
All enrolled subjects will return to the surgeon's office at Week 6 to have their index knee range of motion measured by the PI or study coordinators using the MED device with the goal of achieving a minimum flexion of 120 degrees and an extension of 0 degrees.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Measuring Every Day Device, Physical Therapy
- Keywords
- physical therapy post total knee replacement, range of motion, goniometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring Every Day DeviceDevice
Also called MED Device
Physical TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Standard of care physical therapy | Active comparator | Patients will receive 2 weeks of in-home physical therapy consisting of 3 sessions per week followed by 4 weeks of outpatient physical therapy three times weekly. Receives: Other: Physical Therapy |
| MED Device | Active comparator | Patients will perform 10 repetitions with the MED device 3 times daily at 8am, 2pm, and 8pm and will transmit the 10th measurement of each time point to the clinicians office. Receives: Device: Measuring Every Day Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index Knee Flexion of 90 degrees
Measured: 2 weeks post-op
Index Knee Extension of -25 degrees
Measured: 2 weeks post-op
Index Knee Flexion of 120 degrees
Measured: 6 weeks post-op
Index Knee Extension of 0 degrees
Measured: 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion14 Jun 2018
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Michael Swank, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010605
- Sponsor's protocol ID
- MED
- Acronym
- MED
- Status last verified
- Jul 2018
- First submitted
- 3 Jan 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Measuring Every Day, Patient Incentive Device, as an Adjunct to Conventional Physical Therapy in the Acceleration of Flexion and Extension Capability in the Post-Operative Total Knee Arthroplasty Patient: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03010605
- Acronym / sponsor ID
- MED / MED
- Conditions
- Total Knee Arthroplasty
- Keywords
- physical therapy post total knee replacement, range of motion, goniometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- 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.
Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for return to optimum function. Traditionally, adequate range of motion has been achieved by a combination of in-home and outpatient physical therapy. While physical therapy is successful, it has the limitation of cost and availability. As copayments rise, patients may decide that they cannot afford physical therapy, potentially compromising the outcome of their surgery and successful return to function.
It is assumed that having an easy and fun to use, patient administered, incentive device that provides accurate, quantitative flexion and extension measurements may accelerate patient mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer is commercially available and provides objective, consistent range of motion measurements that are recorded and can be sent electronically to the clinician's office potentially enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.
Goniometry is a commonly used tool to measure and document range of motion (ROM) during clinical evaluation or a physical therapy examination. The technique is used to assess the limitations of a patient's joint and provide information to the clinician that may help determine further treatment.
The study is designed to compare range of motion measurement data for 6 weeks in patients that have been randomized to receive either traditional physical therapy or the MED device. The hypothesis is that patients who use the MED device achieve equivalent range of motion at six weeks as compared to patients participating in traditional standard of care physical therapy.
Detailed description
The MED is a commercially available, digital range of motion monitoring device for patients recovering from knee surgery. It displays both flexion and extension measurements and has the option of connecting to an Apple or Android device to send data to the clinician's office for review. Patients will have the capability to log on to the Measuring Every Day website with an assigned username and a password which they create. This will allow them to view their progress and send messages to the study team. Study team members will also have access to this website for review and the ability to send and receive messages. All shared files will reside on an Amazon HIPAA compliant platform.
This is a prospective, randomized, unblinded, single-center study to compare the MED device to traditional physical therapy. The study will include 46 patients who have undergone successful, unilateral total knee arthroplasty. All patients will receive a minimum of 2 physical therapy sessions prior to hospital discharge and also be instructed to flex and extend their operative knee 10 times every 15 minutes while awake as per standard of care after discharge. Patients will be randomized in a 1:1 ratio prior to discharge from the hospital to either: 1) total knee arthroplasty standard of care rehab which consists of 2 weeks of in-home physical therapy consisting of 3 sessions per week starting within 48 hours of hospital discharge, followed by 4 weeks of out-patient therapy three times weekly, or 2) ten repetitions with the MED device three times daily at 8:00am, 2:00pm and 8:00pm. Patients will transmit the 10th measurement of each time point to the clinician's office. Patients randomized to the MED device will be trained on the use of the device prior to hospital discharge.
All enrolled subjects will return to the surgeon's office at Week 2 to have their index knee range of motion measured by the PI or study coordinators with the MED device. If subjects enrolled in the MED device arm do not have a minimum flexion of 90 degrees and extension of -25 degrees, they will be considered screen failures and return to traditional physical therapy.
All enrolled subjects will return to the surgeon's office at Week 6 to have their index knee range of motion measured by the PI or study coordinators using the MED device with the goal of achieving a minimum flexion of 120 degrees and an extension of 0 degrees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care physical therapy | Active comparator | Other: Physical TherapyPatients will receive 2 weeks of in-home physical therapy consisting of 3 sessions per week followed by 4 weeks of outpatient physical therapy three times weekly. |
| MED Device | Active comparator | Device: Measuring Every Day DevicePatients will perform 10 repetitions with the MED device 3 times daily at 8am, 2pm, and 8pm and will transmit the 10th measurement of each time point to the clinicians office. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is able to provide written informed consent.
- Age 18 - 64 years of age
- Subject has undergone successful unilateral total knee arthroplasty for degenerative joint disease
- Subject has access to an Apple device with Bluetooth capability
- Subject is able to demonstrate the capability of setting up and using an Apple application for remote data collection and transmission
Key exclusion criteria (4 listed)
- Subject is scheduled for an index knee revision surgery
- Subject has pre-operative flexion range of motion less than 110 degrees
- Subject has a pre-operative flexion contracture greater than 15 degrees.
- Subject has additional joint replacement surgery scheduled within the six week study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring Every Day DeviceAlso: MED Device | Device | MED Device |
| Physical Therapy | Other | Standard of care physical therapy |
Primary outcome
Index Knee Flexion of 90 degrees
Time frame: 2 weeks post-op
Index Knee Extension of -25 degrees
Time frame: 2 weeks post-op
Index Knee Flexion of 120 degrees
Time frame: 6 weeks post-op
Index Knee Extension of 0 degrees
Time frame: 6 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring Every Day Device and Physical Therapy in people with Total Knee Arthroplasty, run by The Christ Hospital 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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?
Results are not available in the source record.
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?
Index Knee Flexion of 90 degrees (time frame: 2 weeks post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2018.