Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Stefano Bini

Description

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.

Details

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.

Keywords

Osteoarthritis, Knee Osteoarthritis, Hip Knee Replacement Knee Arthroplasty Hip Replacement Hip Arthroplasty Joint Replacement Physical Therapy Partial Knee Replacement Hip Pain, Chronic Knee Pain, Chronic Osteoarthritis mymobility with Apple Watch

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • Hoag Orthopedic Institute accepting new patients
    Irvine California 92618 United States

Lead Scientist

  • Stefano Bini
    Dr. Stefano Bini, MD was born in Italy, raised in Australia (he still has a slight Aussie accent) and finished high school in San Francisco. He received his BA from Stanford University, his MD from Columbia University’s College of Physician and Surgeons, and completed Residency training at UCSF.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zimmer Biomet
ID
NCT03737149
Study Type
Interventional
Last Updated