mymobility App + Apple Watch for Osteoarthritis Recovery

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartphone app and an Apple Watch can aid recovery from knee surgery as effectively as, or better than, traditional physical therapy. Participants will use the app, mymobility with Apple Watch, to guide exercises and track activity after surgery. This trial suits individuals who have undergone knee surgery, own an iPhone, and can walk using no more than one cane or crutch. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve recovery options for future patients.

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.

What prior data suggests that the mymobility app with Apple Watch is safe for osteoarthritis recovery?

Research shows that the mymobility App, when paired with an Apple Watch, functions as a virtual member of the healthcare team. This setup supports and guides patients, particularly after surgeries like hip or knee replacements. However, specific safety data for this technology is not yet available.

The trial for this app and watch system is labeled as "Not Applicable" in terms of phase, indicating that the safety of the app and watch combination might not have been thoroughly tested. This does not imply it is unsafe, but it suggests that complete safety information is not yet available.

The app and watch connect patients with their healthcare team remotely, aiding in recovery management. Consider it a digital companion that monitors progress and activity.

Overall, while the app and watch offer promising possibilities, they remain relatively new in the medical field. Always consult a healthcare provider to determine if this technology is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mymobility with Apple Watch treatment because it offers a high-tech approach to osteoarthritis recovery that combines education and exercise guidance via a mobile app with precise activity tracking. Unlike traditional physical therapy, which relies on standard exercises and in-person sessions, this treatment allows patients to engage in personalized rehabilitation at their own convenience, potentially increasing adherence and motivation. The Apple Watch's sensitive activity monitoring provides real-time feedback, enabling more tailored adjustments to recovery plans and possibly leading to faster and more effective rehabilitation outcomes.

What evidence suggests that the mymobility with Apple Watch is effective for osteoarthritis recovery?

This trial will compare the use of the mymobility app with an Apple Watch to standard physical therapy for osteoarthritis recovery. Studies have shown that the mymobility app with an Apple Watch can enhance recovery from hip and knee surgeries more effectively than traditional physical therapy. One study found that fewer patients using the app required additional physical therapy compared to those who did not use it. Another study demonstrated that the app improved movement, reduced pain, and increased the range of motion. Participants reported that the app was easy to use and provided a positive experience. These findings suggest that mymobility with Apple Watch could be an excellent option for post-surgery recovery. ^{1 2 6 7 8}

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

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]

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]

Citations

1. investor.zimmerbiomet.com investor.zimmerbiomet.com/news-and-events/news/2021/08-31-2021-150133095

Zimmer Biomet Announces New Data Supporting Clinical ... ... mymobility application with an Apple Watch. Outcomes assessed were physical therapy (PT) visits, readmissions and emergency department (ED)/ ...

2. withpower.com withpower.com/trial/phase-osteoarthritis-knee-9-2018-dc972

mymobility App + Apple Watch for Osteoarthritis Recovery 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10815320/

Problems and Opportunities of a Smartphone-Based Care ... The first survey, focused on the technical aspects of the myMobility app, unveiled an overwhelmingly positive response from participants. A remarkable 100% of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540321006471

A Smartwatch Paired With A Mobile Application Provides ... Compared to conventional rehabilitation, application-based telerehabilitation provides more effective results in function, pain and ROM. Furthermore, mobile ...

5. ryortho.com ryortho.com/2022/11/mymobility-with-apple-watch-reduces-need-for-traditional-pt/

mymobility With Apple Watch Reduces Need for Traditional ... Significantly fewer patients in the mymobility with Apple Watch group required post-operative physical therapy (60.6% vs. 94.6%). Overall KOOS, ...

6. apps.apple.com apps.apple.com/us/app/mymobility-patient-app/id1438566065

mymobility Patient App on the App Store - Apple Your Journey. Your Progress.Your Recovery. The mymobility®app is your digital health companion, bridging the gap between you and your care team.

7. prnewswire.com prnewswire.com/news-releases/zimmer-biomet-announces-new-data-supporting-clinical-benefits-of-mymobility-with-apple-watch-at-aaos-2021-301365583.html

Zimmer Biomet Announces New Data Supporting Clinical ... mymobility with Apple Watch also enables virtual connections between patients and healthcare professionals throughout the surgical episode of ...

8. orthofeed.com orthofeed.com/2020/11/14/zimmer-biomet-shares-early-data-on-apple-watch-app-for-recovery-after-knee-surgery/

Zimmer Biomet shares early data on Apple Watch app for ... Early data showed that Zimmer Biomet's MyMobility app yielded similar results to patients who received traditional care after knee surgery.