Clinical trial NCT03737149: A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Official title: A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Knee Replacement
Knee Arthroplasty
Hip Replacement
Hip Arthroplasty
Joint Replacement
Physical Therapy
Partial Knee Replacement
Hip Pain, Chronic
Knee Pain, Chronic
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase II (RCT): Readmission Rate
timeFrame: 30 Days postop
Secondary outcomes:
measure: Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR)
timeFrame: 90 Days
measure: Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR)
timeFrame: 90 Days
measure: Phase II RCT: EQ-5D-5L
timeFrame: 90 Days
measure: Phase II RCT: Incidence of Manipulation under Anesthesia (MUA)
timeFrame: 90 Days
measure: Phase II RCT: Timed Up and Go (TUG)
timeFrame: 90 Days
measure: Phase II RCT: Single-Leg Stance (SLS) Test
timeFrame: 90 Days
measure: Phase II RCT: Subject Satisfaction
timeFrame: 90 Days
measure: Phase II RCT: Healthcare Costs
timeFrame: 90 Days
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Sah Orthopaedic Associates
state: California
city: Irvine
country: United States
facility: Hoag Orthopedic Institute
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Golden
country: United States
facility: Panorama Orthopedics & Spine Center
state: Colorado
city: Temple Terrace
country: United States
facility: Foundation for Orthopedic Research and Education
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Center for Joint Replacement
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Orthopaedics
state: Kentucky
city: Bethesda
country: United States
facility: OrthoBethesda
state: Maryland
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Rochester Hills
country: United States
facility: Ascension Medical Group - University Orthopaedic Specialists
state: Michigan
city: Troy
country: United States
facility: Michigan Orthopaedic Surgeons
state: Michigan
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Montvale
country: United States
facility: Rothman Institute
state: New Jersey
city: Alburquerque
country: United States
facility: New Mexico Orthopaedic Associates
state: New Mexico
city: Morrisville
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: New Albany
country: United States
facility: JIS Orthopedics
state: Ohio
city: Portland
country: United States
facility: Orthopedic + Fracture Specialists
state: Oregon
city: Tualatin
country: United States
facility: ROC Orthopedics
state: Oregon
city: Bryn Mawr
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Canberra
country: Australia
facility: National Capital Private Hospital
state: Australian Capital Territory
city: Richmond
country: Australia
facility: Epworth Healthcare - Richmond
state: Victoria
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Geldrop
country: Netherlands
facility: St. Annaziekenhuis
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: