Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

NCT04379921 | Completed Results FDA Device

• 1 other identifier: 52367
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Disease; Spine Degeneration; Spinal Stenosis; Surgery; Spine Fusion

Keywords

Spine Surgery; Apple Watch; Objective Tracking of Spine Surgery Outcomes

Outcome Measures

Primary Outcomes (16)

• Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

  Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.

  2-6 weeks pre-operatively

• Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

  Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.

  4-6 weeks post-operatively

• Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

  Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.

  6 weeks-3 months post-operatively

• Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

  Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.

  3-6 months post-operatively

• Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

  Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.

  6-12 months post-operatively

• Change in Objective Outcome Measures: Number of Steps After Surgery

  Steps per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).

  2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively

• Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery

  Meters per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).

  2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively

• Patient Compliance With Wearing Apple Watch - Wear Time

  Average hours wear time per day across the outcome measure time frame.

  2-6 weeks pre-operatively

• Patient Compliance With Wearing Apple Watch - Wear Time

  Average hours wear time per day across the outcome measure time frame.

  4-6 weeks post-operatively

• Patient Compliance With Wearing Apple Watch - Wear Time

  Average hours wear time per day across the outcome measure time frame.

  6 weeks-3 months post-operatively

• Patient Compliance With Wearing Apple Watch - Wear Time

  Average hours wear time per day across the outcome measure time frame.

  3-6 months post-operatively

• Patient Compliance With Wearing Apple Watch - Wear Time

  Average hours wear time per day across the outcome measure time frame.

  6-12 months post-operatively

• Patient Satisfaction With Their Spine Care

  Reported as the number of participants, by response category.

  6 weeks post-operatively

• Patient Satisfaction With Their Spine Care

  Reported as the number of participants, by response category.

  3 months post-operatively

• Patient Satisfaction With Their Spine Care

  Reported as the number of participants, by response category.

  6 months post-operatively

• Patient Satisfaction With Their Spine Care

  Reported as the number of participants, by response category.

  12 months post-operatively

Study Arms (2)

Control

NO INTERVENTION

Participants will receive standard care.

Apple Watch and App

EXPERIMENTAL

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

Device: Apple Watch and App

Interventions

Apple Watch and App DEVICE

Participants in the Apple Watch and App arm will receive an Apple Watch and download an App (NeuroCoach). The Apple Watch and App are used for this study to record patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.

Apple Watch and App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking.
• Undergoing elective spine surgery by attending physicians at Stanford University.
• Own iPhone

You may not qualify if:

• Patients with spine trauma, tumors, or infection.

Sponsors & Collaborators

• Stanford University: lead
• Stryker Nordic: collaborator

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (15)

• Bernstein DN, Brodell D, Li Y, Rubery PT, Mesfin A. Impact of the Economic Downturn on Elective Lumbar Spine Surgery in the United States: A National Trend Analysis, 2003 to 2013. Global Spine J. 2017 May;7(3):213-219. doi: 10.1177/2192568217694151. Epub 2017 Apr 6.

  PMID: 28660102 BACKGROUND

• Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.

  PMID: 8059266 BACKGROUND

• O'Lynnger TM, Zuckerman SL, Morone PJ, Dewan MC, Vasquez-Castellanos RA, Cheng JS. Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America. Neurosurgery. 2015 Oct;77 Suppl 4:S136-41. doi: 10.1227/NEU.0000000000000945.

  PMID: 26378351 BACKGROUND

• Parker SL, Chotai S, Devin CJ, Tetreault L, Mroz TE, Brodke DS, Fehlings MG, McGirt MJ. Bending the Cost Curve-Establishing Value in Spine Surgery. Neurosurgery. 2017 Mar 1;80(3S):S61-S69. doi: 10.1093/neuros/nyw081.

  PMID: 28350948 BACKGROUND

• Epstein NE. A review article on the benefits of early mobilization following spinal surgery and other medical/surgical procedures. Surg Neurol Int. 2014 Apr 16;5(Suppl 3):S66-73. doi: 10.4103/2152-7806.130674. eCollection 2014.

  PMID: 24843814 BACKGROUND

• Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.

  PMID: 26571179 BACKGROUND

• Lu TC, Fu CM, Ma MH, Fang CC, Turner AM. Healthcare Applications of Smart Watches. A Systematic Review. Appl Clin Inform. 2016 Sep 14;7(3):850-69. doi: 10.4338/ACI-2016-03-R-0042.

  PMID: 27623763 BACKGROUND

• Reeder B, David A. Health at hand: A systematic review of smart watch uses for health and wellness. J Biomed Inform. 2016 Oct;63:269-276. doi: 10.1016/j.jbi.2016.09.001. Epub 2016 Sep 6.

  PMID: 27612974 BACKGROUND

• Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157.

  PMID: 29567635 BACKGROUND

• Mobbs RJ, Phan K, Maharaj M, Rao PJ. Physical Activity Measured with Accelerometer and Self-Rated Disability in Lumbar Spine Surgery: A Prospective Study. Global Spine J. 2016 Aug;6(5):459-64. doi: 10.1055/s-0035-1565259. Epub 2015 Oct 13.

  PMID: 27433430 BACKGROUND

• Phan K, Mobbs RJ. Long-Term Objective Physical Activity Measurements using a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody Fusion Surgery. Asian Spine J. 2016 Apr;10(2):366-9. doi: 10.4184/asj.2016.10.2.366. Epub 2016 Apr 15.

  PMID: 27114781 BACKGROUND

• Breteler MJ, Janssen JH, Spiering W, Kalkman CJ, van Solinge WW, Dohmen DA. Measuring Free-Living Physical Activity With Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study. JMIR Form Res. 2019 Apr 24;3(2):e11489. doi: 10.2196/11489.

  PMID: 31017587 BACKGROUND

• Veerabhadrappa P, Moran MD, Renninger MD, Rhudy MB, Dreisbach SB, Gift KM. Tracking Steps on Apple Watch at Different Walking Speeds. J Gen Intern Med. 2018 Jun;33(6):795-796. doi: 10.1007/s11606-018-4332-y.

  PMID: 29633143 BACKGROUND

• Xie J, Wen D, Liang L, Jia Y, Gao L, Lei J. Evaluating the Validity of Current Mainstream Wearable Devices in Fitness Tracking Under Various Physical Activities: Comparative Study. JMIR Mhealth Uhealth. 2018 Apr 12;6(4):e94. doi: 10.2196/mhealth.9754.

  PMID: 29650506 BACKGROUND

• Maldaner N, Tang M, Fatemi P, Leung C, Desai A, Tomkins-Lane C, Zygourakis C. Standardizing Physical Activity Monitoring in Patients With Degenerative Lumbar Disorders. Neurosurgery. 2024 Apr 1;94(4):788-796. doi: 10.1227/neu.0000000000002755. Epub 2023 Nov 13.

  PMID: 37955445 DERIVED

Related Links

• 2017 Profile of Older Americans
• Global Smartwatch Vendor Market Share

MeSH Terms

Conditions

Spinal Diseases; Spinal Stenosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Corinna Zygourakis, MD
• Organization: Stanford University

corinnaz@stanford.edu

(650) 723-6469

Study Officials

• Corinna Zygourakis, MD

  Department of Neurosurgery at Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 8, 2020
• Study Start: September 1, 2020
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)