A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

Zimmer Biomet

Status

Active, not recruiting

Conditions

Osteoarthritis, Hip

Osteoarthritis, Knee

Treatments

Other: mymobility with Apple Watch

Study type

Interventional

Funder types

Industry

Identifiers

NCT03737149

CLU2018-13CH

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subject must be 18 years of age or older.
Subject qualifies for a primary, unilateral total or partial knee arthroplasty, based on physical exam and medical history.
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.
Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App.
Subject is willing and able to complete the protocol required follow-up.
Subject is able to read and understand the language used in the mymobility App for their region.
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.
Subject is mobile with no more than a single cane/single crutch assist preoperatively.

Exclusion Criteria

Subject is a current alcohol or drug abuser as defined by the investigator.
Subject is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
Subject has systemic inflammatory arthropathies which would interfere or compromise the activity profiles within this study.
Subject is currently participating in any other surgical intervention, physical therapy or pain management study which would compromise the results of this study.
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.