mymobility App + Apple Watch for Osteoarthritis Recovery

Recruiting at 36 trial locations

Overseen By Nicolas Piuzzi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Alcohol or drug abuse, Inflammatory arthropathies, Protected population, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 months

10500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if a smartphone app and fitness trackers can help patients recover better after knee or hip replacement surgeries compared to traditional physical therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the mymobility App + Apple Watch safe for use in humans?

The research does not provide specific safety data for the mymobility App + Apple Watch, but wearable technologies like smartwatches are generally considered safe and are used for monitoring health conditions such as osteoarthritis. ^{1 2 3 4 5}

How is the mymobility App + Apple Watch treatment for osteoarthritis different from other treatments?

The mymobility App combined with the Apple Watch is unique because it uses wearable technology to monitor physical activity and provide digital support, which can empower patients to manage their osteoarthritis more effectively and improve communication with healthcare providers. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment mymobility with Apple Watch for osteoarthritis recovery?

Research shows that wearable technology, like smartwatches, can help people with knee osteoarthritis by tracking physical activity and pain levels, which may improve their management of the condition. Additionally, patients who have undergone knee surgery are generally receptive to using wearable technology for monitoring their recovery. ^{1 4 5 10 11}

Who Is on the Research Team?

Erin Osborn

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

Adults over 18 needing a primary knee arthroplasty, who can walk with minimal assistance and own an iPhone compatible with the mymobility App. They must be able to understand the app's language and consent to participate. Excluded are those with systemic inflammatory diseases, current substance abuse issues, or involvement in other related studies.

Inclusion Criteria

Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App.

Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App

My treatment includes a device that will be used as the manufacturer intended.

Exclusion Criteria

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 which would compromise the results of this study

I need both of my joints replaced, either at the same time or within 90 days of each other.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

In-office assessments conducted approximately 30 days prior to surgery

4 weeks

1 visit (in-person)

Treatment

Participants undergo TKA, THA, or PKA and complete post-operative activities using the mymobility app or standard physical therapy

3 months

1 visit (in-person) at 30 days post-op, 1 visit (in-person) at 3 months post-op

Follow-up

Virtual assessments including subject questionnaires and recording of adverse events at 6 months and 1 year post-op

9 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• mymobility with Apple Watch

Trial Overview The study is testing if using the mymobility platform with an Apple Watch for education and exercise guidance can replace or improve upon standard physical therapy after hip or knee replacement surgery.

How Is the Trial Designed?

Group I: mymobility with Apple Watch Experimental Treatment 1 Intervention

Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.

Group II: Standard of Care Physical Therapy Active Control 1 Intervention

Standard of care patient education and post-operative physical therapy, as determined by local site guidelines and care pathways.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Published Research Related to This Trial

A feasibility study involving 26 participants with knee osteoarthritis demonstrated that smartwatches can effectively track daily pain levels and step counts in real time, providing valuable data on day-to-day variability in pain.

Participants with fluctuating pain levels had significantly lower average step counts compared to those with sustained high or low pain, suggesting a potential link between pain variability and physical activity that warrants further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Day-to-day variability of knee pain and the relationship with physical activity in people with knee osteoarthritis: an observational, feasibility study using consumer smartwatches. Vivekanantham, A., Selby, D., Lunt, M., et al.[2023]

The Motion Coach app provides real-time audiovisual feedback on exercise execution for patients with osteoarthritis and shows interrater agreement with physiotherapists that is comparable to evaluations made by two different physiotherapists, indicating its reliability.

In a study involving 24 participants, the Motion Coach app demonstrated noninferior performance in assessing exercise form, suggesting it can effectively support rehabilitation for musculoskeletal disorders without significant differences in accuracy across various age, gender, or BMI subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study. Biebl, JT., Rykala, M., Strobel, M., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Day-to-day variability of knee pain and the relationship with physical activity in people with knee osteoarthritis: an observational, feasibility study using consumer smartwatches. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Perceptions about smartphone-based interventions to promote physical activity in inactive adults with knee pain - A qualitative study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Applications of Wearable Technology in a Real-Life Setting in People with Knee Osteoarthritis: A Systematic Scoping Review. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Patient Perceptions of Wearable and Smartphone Technologies for Remote Outcome Monitoring in Total Knee Arthroplasties. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Perception of Older Adults Toward Smartwatch Technology for Assessing Pain and Related Patient-Reported Outcomes: Pilot Study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Impact of wearable technology on psychosocial factors of osteoarthritis management: a qualitative study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Computer-based patient education for older persons with osteoarthritis. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Experiences of activity monitoring and perceptions of digital support among working individuals with hip and knee osteoarthritis - a focus group study. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Let's Move with Leon. A randomised controlled trial of a UK digital intervention to improve physical activity in people with a musculoskeletal condition. [2023]