N/A
N=11
Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor
Cervical Spine Fusion
Bottom Line
View on ClinicalTrials.gov: NCT04921800 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Vibrational Frequency of Vocalization Following Surgery
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anterior Cervical Discectomy & Fusion (Procedure); Application of ADAM mechanoacoustic skin sensor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vibrational Frequency of Vocalization Following Surgery |
— | — |
| PRIMARY Skin Temperature of the Surgical Site |
— | — |
| PRIMARY Muscular Force Generated During Range of Motion Exercises |
— | — |
| PRIMARY Algorithm Validation |
67.5 | — |
Summary
The purpose of this study is to assess the function and reliability of a noninvasive, skin-like electronic sensor. The investigators hypothesize that this skin sensor will address an unmet need to wirelessly and noninvasively monitor and characterize the recovery process in post-operative patients who have undergone anterior cervical discectomy and fusion (ACDF). Specifically, the investigators will validate the use of the sensor in this patient population through monitoring of key physiological signals in the recovery process, including heart rate, respiratory rate, swallow count, talking time, energy expenditure, neck specific motion, and body orientation.
Eligibility Criteria
Inclusion Criteria
- Patients who have undergone anterior cervical discectomy and fusion (ACDF) for one or more levels for a diagnosis of cervical radiculopathy or myelopathy
- Scheduled to return to the MSK orthopaedic clinic for a post-operative appointment
- Aged between 18 to 88 years at time of surgery
Exclusion Criteria
- Patients that underwent a revision of previous ACDF surgery at one or more operative levels
- Surgeries performed for a traumatic or oncologic etiology
- Members of vulnerable populations (i.e. prisoners, pregnant women)
Data sourced from ClinicalTrials.gov (NCT04921800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.