|Principal Investigator: Jeremy Gililland|
|Keywords: Total Joint Arthroplasty , Mobility , Value , Physical Function||Department: Orthopedic Surgery Operations|
|IRB Number: 00116363|
|Specialty: Orthopaedic Surgery|
|Sub Specialties: Adult Reconstruction|
|Recruitment Status: Recruiting|
The purposes of the study are to evaluate the following measures and, as applicable, compare them to the comparator group results:
1. Determine if physical measurements and PROMs are similar between groups
2. Determine if subject satisfaction is higher in the study group
3. Determine the economic benefits to practices and payers
4. Determine if complication outcomes are similar in the study group
5. Determine if the combination of data collected through an episode of care management application on a mobile platform combined with objective physical measurements can be utilized to predict the probability of post-operative complications, discharge disposition, ROM, and other PROM scores. This data set will also be used for future product feature development such as risk stratification, correlative signature modeling, and algorithm development.
Primary Objectives: The study objectives are to evaluate clinical outcomes, economics, and satisfaction with mymobility and the Apple Watch while developing a correlative heuristic considering multiple endpoints within the Zimmer Biomet THA, TKA and PKA populations. To accomplish the objectives of this multifaceted protocol, the study has been broken into three cohorts with varying objectives. All study subjects will ultimately be part of the Correlative Analytics cohort. Additional objectives for each cohort are listed below.
A. Pilot & Time Cohort (Phase I)
1. Determine study onboarding requirements (time and staff)
2. Determine time required for instrumentation of mymobility app and Apple Watch
3. Determine study execution requirements (time and staff)
4. Verify enrollment assumptions and customized survey content
5. Determine time required to attain subject understanding of use of Apple Watch features (steps, stand hours, active calories, exercise minutes, heart rate - resting, walking, variability, flights climbed)
B. Randomized Controlled Trial (RCT) Cohort (Phase II)
1. Demonstrate non-inferiority of the study group, when measuring 30-day all cause readmission rates, when compared to the control group who will undergo standard of care education and outpatient PT regimen.
1. Demonstrate non-inferiority of the study group in the number of readmissions through 30 days post-op.
1. Non-inferiority of the mymobility cohort for PROMs (HOOS Jr, KOOS Jr) and EQ-5D-5L.
2. Manipulation Rates (knee), Timed Up and Go (TUG) and single leg stance test (SLS).
3. Satisfaction/Engagement: Assess differences between the study groups in subject satisfaction from Custom Satisfaction Survey(s).
4. Resource Utilization: Assess differences in resource-utilization in the study group for the entire episode of care (90 days postoperative). Potential data collection points include number of PT visits, discharge disposition, ER visits, readmissions, reoperations, unscheduled surgeon visits, and reduction in time processing paperwork and approvals from PT.
C. Correlative Analytics Cohort (Phase III)
In additional to traditional data collection mechanisms, four passive outcome measures will be captured among all study subjects via the Apple Watch sensors in combination with the mymobility app, attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. These correlative outcomes will be measured using steps, stand hours, active calories, exercise minutes, heart rate (average, resting, walking, and variability), and flights climbed that will be analyzed in statistical models (including multivariate regression models). Details and methodology are provided in Section XV (Statistical Methods).
1. Assess the differences in episode of care data compiled, collected, and delivered in the mymobility platform to correlate the incidence of the 7 most common post TJR medical complications (UTI, ileus, MI, pneumonia, DVT/PE, prolonged wound drainage, wound infection).
2. Assess the ability of PREOP and episode of care data compiled, collected, and delivered in the mymobility application (from, among other sources, the Apple Watch sensor platform) to correlate with discharge disposition (home vs. non-home - ACF or SNF)
3. Identify 90-day mymobility data points which correlate with 30-day post op ROM data (90 degrees of flexion) within the TKA and PKA populations.
4. Assess the ability of POSTOP data compiled, collected, and delivered in the mymobility application (from, among other sources, the Apple Watch sensor platform) collected during PODs 0-90 to predict which subjects will have a “very satisfied” or “satisfied” score on Patient Satisfaction component of the Patient Questionnaire #3 at 90 days.
1. Utilize the unique patient clinical data that is available with the mymobility application to correlate early post-operative outcomes of Zimmer Biomet implants to preoperative and postoperative activity profiles, surgical techniques, patient attributes, and other routine outcomes data collected.
2. To provide a real-world data set on the mymobility cohort, including physiologic monitoring data, that enables ongoing exploratory data analysis and retrospective cohort study that will inform future product feature development. An example of such analysis that would support surgeons to make patient-specific recommendations is: study subjects could be “binned” according to 5-year age grouping (age 30-34, 35-39, etc.) and BMI (20-24, 25-30, etc.), and regression analysis could be used to correlate watch sensor data with superior outcomes. Statistically valid correlations would enable product features that support a surgeon to more easily identify whether or not a given patient’s activity is following a pattern associated with superior clinical outcome.
The study population for primary statistical analysis will be comprised of males and females who require primary, unilateral partial or total knee arthroplasty or total hip arthroplasty and satisfy the inclusion/exclusion criteria outlined in this section of the protocol. In order to avoid potential selection bias during the RCT phase of the study, each Investigator will offer study participation to each eligible patient presenting as a candidate for primary unilateral, partial or total knee arthroplasty or total hip arthroplasty using any commercially available (e.g. FDA cleared/approved) Zimmer Biomet devices or on-label devices from other brands for PKA, TKA or THA surgeries. Eligible candidates who express interest in study participation will be offered Informed Consent and Authorization.
|Subject must be 18 years of age or older.|
• Subject qualifies for a primary, unilateral total or
partial knee arthroplasty, or total hip arthroplasty based on physical exam or medical history
|Subject is a current alcohol or drug abuser.|
• Subject has inflammatory arthropathies which would
interfere or compromise the activity profiles within
• Subject is considered a member of a protected
population (e.g., prisoner, mentally incompetent,
• Subject is currently participating in any other surgical
intervention, physical therapy or pain management
study which would compromise the results of this
• 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,
Additionally, subjects who complete the entire study (1 year)
for one joint may be enrolled for a second joint.