Apple Watch Tracking for Spinal Surgery Recovery

Overseen By Megan Tang, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Spine trauma, tumors, infection

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

What is the purpose of this trial?

One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.

Research Team

Corinna Zygourakis, MD

Principal Investigator

Department of Neurosurgery at Stanford University

Eligibility Criteria

This trial is for English-speaking individuals who are scheduled for elective spine surgery at Stanford University and own an iPhone. It's not open to patients with tumors, spine trauma, or infections.

Inclusion Criteria

English-speaking

I am scheduled for spine surgery at Stanford University by its attending physicians.

I own an iPhone.

Exclusion Criteria

I have had a spine injury.

I have an infection in my spine.

I have a tumor in my spine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Monitoring

Participants are monitored using the Apple Watch to track baseline activity levels before elective spine surgery

4 weeks

1 visit (in-person) for baseline assessment

Post-Surgery Monitoring

Participants use the Apple Watch to track activity and discuss mobilization goals with their surgeon post-operatively

12 months

Regular virtual check-ins and in-person visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Apple Watch and App

Trial Overview The study tests the use of the Apple Watch and a companion app to track patient activity before and after elective spine surgery. The goal is to see if this technology can help improve patient empowerment, satisfaction, and self-reported outcomes.

Participant Groups

Group I: Apple Watch and App Experimental Treatment 1 Intervention

Participants will receive standard care, and an Apple Watch to record activity through the App.

Group II: Control Active Control 1 Intervention

Participants will receive standard care.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Stryker Nordic

Industry Sponsor

Trials

35

Recruited

4,400+