What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include guided education, exercise, and activity monitoring, often facilitated through mobile applications and wearables. These non-pharmacologic interventions generally have minimal side effects, though some patients may experience temporary muscle soreness or fatigue from increased physical activity. Pharmacologic treatments like NSAIDs, which are sometimes used in conjunction with these interventions, can have side effects such as gastrointestinal issues, cardiovascular risks, and renal complications. It is important to monitor these side effects and consult with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) and duloxetine for pain management. However, specific treatments involving mobile application-guided education and exercise paired with wearable activity monitoring are not mentioned as FDA-approved. Broadly, the use of mobile health technologies, such as apps for real-time feedback on activity and pain, is being studied for their potential benefits in managing osteoarthritis symptoms.

What other types of research exist?

Promising alternatives to mobile application-guided education and exercise with wearable activity monitoring for osteoarthritis patients include: 1) Home-based pedometer-driven walking programs combined with arthritis self-management education, which have shown to increase physical activity, muscle strength, and functional performance. 2) Web-based physical activity interventions, which provide structured exercise programs and have demonstrated effectiveness in increasing physical activity levels. 3) Tailored activity pacing interventions, which customize activity levels based on individual symptoms and have been effective in reducing pain and fatigue. 4) Telemedicine, which offers remote patient monitoring and virtual consultations, expanding access to care and providing personalized treatment plans.

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Behavioural Intervention

mymobility App + Apple Watch for Osteoarthritis Recovery

N/A

Waitlist Available

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Subject must be 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a mobile application and activity monitoring rather than medication, traditional side effects are not applicable. However, participants may experience discomfort from increased activity levels encouraged by the app.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move around but may need a cane or crutch.

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I am 18 years old or older.

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I am eligible for knee replacement surgery based on my medical history and physical exam.

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I am eligible for knee replacement surgery based on my medical history and physical exam.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase II (RCT): Readmission Rate

Secondary study objectives

Phase II RCT: EQ-5D-5L

Phase II RCT: Healthcare Costs

Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mymobility with Apple WatchExperimental Treatment1 Intervention

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

Group II: Standard of Care Physical TherapyActive Control1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for osteoarthritis (OA) include analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and exercise therapy. Analgesics like acetaminophen work by reducing pain signals in the brain, while NSAIDs such as ibuprofen and naproxen reduce inflammation and pain by inhibiting enzymes involved in the inflammatory process. Exercise therapy, particularly when guided by mobile applications and monitored through wearables, improves pain and function by enhancing muscle strength, joint stability, and overall physical fitness. This approach also provides real-time feedback and personalized adjustments, which can help patients adhere to their exercise regimens more effectively. Understanding these mechanisms is crucial for OA patients as it empowers them to actively participate in their treatment, potentially leading to better pain management and improved quality of life.