Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
Knee Replacement, Knee Arthroplasty, Hip Replacement, Hip Arthroplasty, Joint Replacement, Physical Therapy, Partial Knee Replacement, Hip Pain, Chronic, Knee Pain, Chronic
Brief summary
Post-market prospective, multi-center longitudinal study to determine if mobile application-guided education and exercise paired with accurate and sensitive activity monitoring, captured from consumer wearables, can provide a viable (and potentially improved) alternative to current standard of care physical therapy for hip and knee arthroplasty.
Detailed description
This is a post-market prospective, multi-center longitudinal study in subjects undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA), or partial knee arthroplasty (PKA). The study objective is to determine if mobile application-guided education and exercise paired with accurate and sensitive activity monitoring, captured from consumer wearables, can provide a viable (and potentially improved) alternative to current standard of care patient education and physical therapy for hip and knee arthroplasty. The study will be conducted in phases. The first phase (N = 300) will consist of a pilot cohort of subjects and will primarily serve to determine site study staffing needs and time required for various elements of study execution. The second phase (N = 1,000, RCT) will consist of a randomized controlled subject cohort and will compare outcomes of mobile application-guided exercises and activity with standard of care (SOC) physical therapy. The third phase (N \ 10,000 including subjects from both Phase I and the study arm from RCT/Phase II) will seek to collect enough data to enable the creation of decision support algorithms for outcomes of joint replacement. All subjects will undergo a TKA, THA, or PKA using SOC procedures and commercially-available devices as part of their clinical care. Subjects will then complete prescribed post-operative activities, such as physical therapy, according to SOC or performing exercises as scheduled through the mymobility app. In office assessments will be conducted at approximately 30 days prior to surgery, 30 days after surgery, and 3 months after surgery. Virtual assessments (including subject questionnaires and recording of adverse events) will occur at approximately 6 months and 1 year post-op. February 2022 update: Eligibility criteria for new patients includes total knee and partial knee arthroplasty surgeries. Previously enrolled total hip arthroplasty patients will remain in the study for follow-up.
Interventions
OTHERmymobility with Apple Watch
The mymobility mobile application is a mobile software platform designed to facilitate remote episode of care management and asynchronous communication between the provider care team and their patient via provider-approved care plans and engagement communications. Current care pathways have been developed for: Total Hip Replacement, Total Knee Replacement and Partial Knee Replacement. Designed for the orthopedic population, mymobility also integrates wearable data from the Apple Watch into provider dashboards, providing enhanced understanding and monitoring of patients throughout the episode of care.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a staged cohort study. In the first (pilot) cohort, all participating subjects will utilize the mymobility with Apple Watch platform. In the second (RCT) cohort, approximately 1,000 subjects will be randomized 1:1 to either the mymobility with Apple Watch platform or standard of care SOC. In the third (correlative analytics) cohort, all participating subjects will utilize the mymobility with Apple Watch platform.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be 18 years of age or older. 2. Subject qualifies for a primary, unilateral total or partial knee arthroplasty, based on physical exam and medical history. 3. Investigator plans to treat subject with a commercially-available device, used on-label according to the manufacturer's instructions for use, as part of their clinical care. 4. Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App. 5. Subject is willing and able to complete the protocol required follow-up. 6. Subject is able to read and understand the language used in the mymobility App for their region. 7. Subject is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB/EC approved Informed Consent Form and Authorization. Where applicable, subject must also be willing to provide authorization for use of protected health information in accordance with local privacy laws. 8. Subject is mobile with no more than a single cane/single crutch assist preoperatively.
Exclusion criteria
1. Subject is a current alcohol or drug abuser as defined by the investigator. 2. Subject is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.). 3. Subject has systemic inflammatory arthropathies which would interfere or compromise the activity profiles within this study. 4. Subject is currently participating in any other surgical intervention, physical therapy or pain management study which would compromise the results of this study. 5. Subject requires simultaneous or staged bilateral replacements, staged\<90 days apart. Subjects can be enrolled into the study for the second, staged arthroplasty if scheduled \>89 days after their first, contralateral replacement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase II (RCT): Readmissions | 30 Days | The number of subjects with a readmission within 30 days after knee or hip replacement surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II (RCT): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) | 90 Days | The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. |
| Phase II (RCT): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) | 90 Days | The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health. |
| Phase II RCT: EQ-5D-5L | 90 Days | The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment of the participant's quality of life. The score ranges from a minimum score of -0.573 to a maximum score of 1, with higher scores indicating higher health utility. Negative numbers correspond to a self-assessed health state worse than being dead. |
| Phase II (RCT): Manipulation Under Anesthesia (MUA) | 90 Days | The number of subjects with a manipulation under anesthesia (MUA) within 90 days after knee replacement surgery. |
| Phase II (RCT): Timed Up and Go (TUG) | 90 Days | Timed Up and Go Test: The time to rise from a chair, walk 10 feet, turn around, walk back to the chair and sit down. |
| Phase II (RCT): Single-Leg Stance (SLS) Test | 90 Days | Balance Test while standing on a single leg. Three tests are performed and the best of the three times is recorded. The maximum time for this test is 60 seconds. |
| Phase II (RCT): Subject Satisfaction | 90 Days | Comparison of subject satisfaction survey results between the study groups. The Knee Society Scoring System (KSS) satisfaction score ranges from 0 to 40, with higher scores indicating greater satisfaction. |
| Phase II RCT: Urgent Care Center and Emergency Room Visits | 90 Days | The number of subjects with urgent care visits or emergency room visits within 90 days after knee or hip replacement surgery. |
| Phase I (Pilot): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) | 90 Days | The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. |
| Phase I (Pilot): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) | 90 Days | The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health. |
| Phase III (Correlative): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) | 90 Days | The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. |
| Phase III (Correlative): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) | 90 Days | The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health. |
Countries
Australia, Italy, Netherlands, United States
Contacts
STUDY_DIRECTORHillary Overholser
Zimmer Biomet
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 19 Participants |
| Race/Ethnicity, Customized Arab or Middle Eastern | 4 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 232 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 116 Participants |
| Race/Ethnicity, Customized Multiracial | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 11 Participants |
| Race/Ethnicity, Customized Not Recorded | 2 Participants |
| Race/Ethnicity, Customized White | 5507 Participants |
| Region of Enrollment Australia | 179 Participants |
| Region of Enrollment Netherlands | 55 Participants |
| Region of Enrollment United States | 210 Participants |
| Sex: Female, Male Female | 864 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 143 | 0 / 63 | 1 / 210 | 0 / 174 | 1 / 245 | 0 / 204 | 7 / 3,867 | 4 / 1,653 |
| other Total, other adverse events | 12 / 143 | 9 / 63 | 27 / 210 | 19 / 174 | 33 / 245 | 19 / 204 | 377 / 3,867 | 137 / 1,653 |
| serious Total, serious adverse events | 5 / 143 | 0 / 63 | 13 / 210 | 11 / 174 | 15 / 245 | 8 / 204 | 179 / 3,867 | 72 / 1,653 |
Outcome results
None listed