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Wearable Sensor Monitoring for Cervical Spine Fusion Recovery

N/A

Waitlist Available

Led By Shuai Xu, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Aged between 18 to 88 years at time of surgery

Patients who have undergone anterior cervical discectomy and fusion (ACDF) for one or more levels for a diagnosis of cervical radiculopathy or myelopathy

Must not have

Surgeries performed for a traumatic or oncologic etiology

Patients that underwent a revision of previous ACDF surgery at one or more operative levels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 24 hours post operative

Awards & highlights

No Placebo-Only Group

Summary

This trialwill test a noninvasive, skin-like electronic sensor to monitor recovery of patients who've had ACDF surgery. Physiological signals like heart rate, respiratory rate, and more will be measured.

Who is the study for?

This trial is for individuals aged 18 to 88 who have had ACDF surgery for cervical radiculopathy or myelopathy and are scheduled for a post-op clinic visit. It excludes those with revised ACDF, surgeries due to trauma or cancer, and vulnerable groups like prisoners or pregnant women.

What is being tested?

The study tests a new wearable skin sensor called ADAM mechanoacoustic sensor on patients after ACDF surgery. It aims to wirelessly monitor recovery by measuring heart rate, breathing rate, swallowing frequency, talking time, energy use, neck motion, and body position.

What are the potential side effects?

Since the intervention involves wearing a noninvasive sensor rather than medication or invasive procedures, significant side effects are not anticipated in this trial.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 88 years old.

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I had surgery to remove a disc in my neck due to nerve or spinal cord issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery due to cancer or an injury.

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I had a revision surgery for my previous neck fusion surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after awaking from sedation in the post-anesthesia care unit and immediately prior to discharge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Algorithm Validation

Muscular Force Generated During Range of Motion Exercises

Skin Temperature of the Surgical Site

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Wearable Sensor AppliedExperimental Treatment2 Interventions

For these participants, the wearable ADAM sensor will be placed in the sternal notch to record anatomical data during the post-surgical period for up to 14 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anterior Cervical Discectomy & Fusion

2015

N/A

~150

0 / 4Eligibility criteria met