A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform



Status:Recruiting
Conditions:Arthritis, Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:October 22, 2018
End Date:December 31, 2021
Contact:Erin Osborn, MBA, CCRP
Email:Erin.Osborn@zimmerbiomet.com
Phone:574-371-9884

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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.

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
Zimmer Biomet 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.

Inclusion Criteria:

- Subject must be 18 years of age or older.

- Subject is indicated for a primary, unilateral total or partial knee arthroplasty, or
total hip arthroplasty based on physical exam and with a medical history diagnosis of
Osteoarthritis (OA).

- Investigator plans to treat subject with a Zimmer Biomet device as part of their
clinical care.

- Subject must own and maintain an iPhone 6 or newer.

- Subject must be willing and able to complete the protocol required follow-up.

- Subjects must be able to read and understand English.

- Subject is willing and able to provide written Informed Consent and Authorization by
signing and dating the IRB approved Informed Consent and Authorization form (ICF).

- Subject is mobile with no more than a single cane/single crutch assist.

Exclusion Criteria:

- Subject is a current alcohol or drug abuser.

- Subject is considered a member of a protected population (e.g., prisoner, mentally
incompetent, etc.).

- Subject is currently participating in any other surgical intervention, physical
therapy or pain management study.

- Subject requires simultaneous or staged bilateral replacements.
We found this trial at
17
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Craig L Israelite, MD
Phone: 215-294-9132
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Thomas L Bradbury, MD
Phone: 404-778-8051
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Jeremy Gililland, MD
Phone: 801-213-0961
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Albuquerque, New Mexico 87106
Principal Investigator: Samuel Tabet, MD
Phone: 505-239-3174
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Albuquerque, NM
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10215 Fernwood Road
Bethesda, Maryland 20817
Principal Investigator: Christopher J Cannova, MD
Phone: 301-530-1010
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Bethesda, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Craig J Della Valle, MD
Phone: 312-432-2470
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Denver, Colorado 80210
Principal Investigator: Todd Miner, MD
Phone: 303-260-2940
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Denver, CO
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Denver, Colorado 80401
Principal Investigator: Jared Foran, MD
Phone: 303-233-1223
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Denver, CO
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Indianapolis, Indiana 46241
Principal Investigator: Wesley Lackey, MD
Phone: 317-455-1064
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Indianapolis, IN
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Irvine, California 92618
Principal Investigator: Steven L Barnett, `MD
Phone: 949-255-9753
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Irvine, CA
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New Albany, Ohio 43054
Principal Investigator: Adolph Lombardi, Jr, FACS, MD
Phone: 614-221-6331
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New Albany, OH
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2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Principal Investigator: Hany S Bedair, MD
Phone: 617-243-6493
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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Newton, MA
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Paramus, New Jersey 07652
Principal Investigator: Gregg R Klein, MD
Phone: 201-291-4040
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Paramus, NJ
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Portland, Oregon 97225
Principal Investigator: Paul J Duwelius, MD
Phone: 503-214-5259
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Rochester Hills, Michigan 48307
Principal Investigator: Jeffrey H DeClaire, MD
Phone: 248-659-0190
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Rochester Hills, MI
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Scottsdale, Arizona 85254
Principal Investigator: David A Camarata, MD
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Tualatin, Oregon 97062
Principal Investigator: James C Ballard, MD
Phone: 503-214-1101
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Tualatin, OR
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