Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
Phase: NA
Conditions: Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery, Spine Fusion
Sponsor: Stanford University

Improving Spine Surgical Care With Real-Time 
Objective Patient Tracking Using the Apple Watch  
Study Protocol 
NCT04379921 
July 31, 2024 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
For patients who undergo spine surgery or are experiencing back pain,  
mobilization is an important factor in long-term medical and psychological wellbeing. 
Unfortunately, there is currently no established objective method such that surgeons can 
track their patients’ mobilization progress postoperatively. We hypothesize the ability of 
the patient to be able 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. The purpose of this 
study is to test our hypothesis using the most prevalent commercially available wearable 
technology, the Apple Watch. 
b. 
Objectives 
In this study, we will address the following questions: 
1. Is it feasible for spine patients to wear the leading commercially available device 
(specifically, the Apple Watch) before and after spine surgery to assist with their spine 
care? 
2. Do objective patient metrics (steps, distance traveled, max HR achieved) obtained 
from this commercially available device directly correlate with subjective patient 
reported outcome measures (PROMs) for spine surgery patients? 
3. Do we see a significant change in objective outcome metrics before and after spine 
surgery? 
4. Are patients more satisfied with their spine care as a result of using the Apple Watch in 
our practice? 
c. 
Rationale for Research in Humans 
The purpose of this study is to assess the efficacy of using a  
commercially available wearable activity monitor (the Apple Watch) in the postoperative 
care of patients undergoing spine surgery. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
This study protocol is similar in parts to previously approved protocol, "Accelerometers 
in spine surgery study," for which Dr. Desai (Co-PD on current proposal) is the PD. 
 

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All English-speaking adult patients (>=18 years old) who are undergoing elective spine 
surgery (excluding patients with spine trauma, tumors, or infection) for Cohort 1 or are 
undergoing any back treatment for Cohort 2 by neurosurgery attending physicians at 
Stanford (Dr. Corinna Zygourakis, Dr. Atman Desai, Dr. Anand Veeravagu, Dr. John 
Ratliff, Dr. Jon Park, Dr. Lawrence Shuer) will be eligible for participation in this study.  
 
All participants in Cohort 1 and Cohort 2 will receive our standard of care.  
 
In Cohort 1, percentage for random assignment to each group is 50%. Those are assigned 
to the "intervention" (i.e., the Apple Watch) will receive instructions on how to use the 
activity section within the Watch. The participants will either have their mobility data 
submitted via the previously approved app Neurocoach. The intervention group will wear 
the Apple watch 2-6 weeks pre-operatively as well as at least 6 months post-operatively 
(may continue to wear as long as 12 months). The control group will not. Patients in the 
interventional group receiving an Apple Watch may be asked to come in for a training 
and set-up visit at clinic. Parking passes will be provided for this visit. 
 
All patients in Cohort 1 will be seen in follow-up clinic as per standard of care (4-6 
weeks, 3 months, 6 months, and 12 months post-operatively). At each time point, all 
patients will complete standardized quality of life questionnaires (several of which are 
already incorporated in our postoperative clinic) and an additional study-specific 
questionnaire regarding satisfaction with their care and recovery. 
 
 
In Cohort 2, all participants will receive an Apple Watch and instructions on how to use 
the activity section within the Watch. The participants will have their mobility data 
submitted via the previously approved app Neurocoach. Participants will wear the Apple 
Watch for 2-3 weeks. Participants will complete standardized quality of life 
questionnaires (several of which are already incorporated in our postoperative clinic) at 
the beginning and end of the 2-3 week study. This cohort will have their pain monitored 
daily using brief questionnaires. 
b. 
Procedure Risks 
Our protocol does not change the standard of care for any patient. It provides a 
supplementary intervention for half of our patients. The intervention is using a wearable 
activity monitor device (the Apple watch), which is a minimal risk. 
c. 
Use of Deception in the Study 
Deception will not be used. 
d. 
Use of Audio and Video Recordings 
Audio or video recording will not occur. 
e. 
Alternative Procedures or Courses of Treatment 
Standard of care will not be withheld. Our study does not involve alternative procedures 
or treatments. 

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f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
All patients will undergo standard of care for their spine surgery before, during, and after 
the study. 
g. 
Study Endpoint(s) 
For Cohort 1, the study endpoint will be 12 months postoperatively. Following 
enrollment during the pre-operative visit, we will see patients in clinic during their 
standard postoperative visits, at 4-6 weeks, 3 months, 6 months, and 12 months post 
operatively. All patients will complete the Stanford Spine quality of life questionnaires, 
as per the standard of care, at all postoperative visits. Patients with the Apple Watch will 
also fill out a paper questionnaire assessing satisfaction with the Apple Watch (all 
questions are included in attachment).  
 
As participants reach the 12-month study period, we will conduct ongoing analysis of the 
data. If we observe clear statistically significant and clinically significant superiority in 
one group, the study will be terminated prior to the projected total participant population 
has been enrolled. If there are no such differences noted, the Cohort 1 will terminate after 
the all patients have had their 12-month postoperative visit, likely July 2023. 
 
For Cohort 2, the study endpoint will be 2-3 weeks after enrollment and Apple Watch 
setup. If we observe clear statistically significant and clinically significant changes, the 
study will be terminated prior to the projected total participant population has been 
enrolled. If there are no such differences noted, the Cohort 2 will terminate after all 
patients have completed the study, likely August 2021. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Our prior research protocol, "Accelerometers in spine surgery study," for which Dr. Desai 
(Co-PD on current proposal) is the PD, has informed the creation of the current protocol. 
In that study, we were used a low-cost accelerometer to objectively assess patient's 
mobility and function before and after elective cervical or lumbar surgery. It showed that 
recovery to baseline occurred for most by 8 weeks postoperatively. 
 
General background 
Spine surgery represents a significant portion of interventional procedures in the United 
States. There is an increasing rate of spine surgeries performed in the United States over 
the past 20 years1,2, which has been driven – in large part – by an aging population.3 This 
is expected to continue to increase, as the US Department of Health and Human Services 
projects the population age 65 and over to double from 49.2 million in 2016 to 98 million 
in 2060.4 Spine degenerative pathologies and disability are highly prevalent, and 
represent a major economic burden; the annual cost of spine care in the US is estimated at 
$100 billion.3,5 The postoperative management and rehabilitation of spine patients 
remains difficult and costly. Early postoperative mobilization of patients reduces 
complications, and is associated with improved survival, decreased length of 

July 31, 2024 
 
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hospitalization, and improved psychological well-being.6 Current methods for evaluating 
postoperative spine patients are limited as these mainly rely on self-reported quality of 
life and pain surveys, which are subjective outcome measures that may be heavily 
influenced by patient perception, psychological state, and other perioperative influences. 
Additionally, the breadth of patient reported outcome measures (PROMs) is extensive 
and unsustainable; for example, Guzman et al. (2016) recently evaluated 19,736 articles 
reporting on spine surgery, and found the use of 206 unique PROMs.7  
 
Wearable activity monitors (WAMs) 
Technological advances in recent years have resulted in novel wearable devices that 
interface with mobile phones and/or computers.8 Such wearable devices, including 
smartwatches developed by Apple, Fitbit, and Samsung, incorporate sophisticated 
biosensors and wireless data communication that allow the wearer to monitor, access, and 
transmit information easily. Given the functionality and accessibility of such biosensors 
capable of wireless information exchange, these devices are poised to become vectors of 
innovative non-invasive monitoring solutions for effortless transmission of physiological 
data.8 As these devices continue to propagate amongst the general public, they have the 
potential to provide health care providers with objective, data-driven information that can 
improve the quality of health care, clinical workflow, and positively influence clinical 
management.9  
 
With advanced sensors on hand10 (including an accelerometer, gyroscope, ECG, and 
heart monitor), and the ability to objectively measure patients’ physical ability (via steps 
per day, distance walked, floors climbed, and calories burned), such technology could 
provide objective measures to supplement the subjective PROMs and provide physicians 
an improved ability to track postoperative mobility outcomes. The Apple Watch Series 4 
obtained class II FDA clearance in 2018 for ECG monitoring and irregular heart rhythm 
notification. Studies have analyzed validity of the Apple Watch for activity metrics. 
Breteler et al. showed that participants gave favorable usability scores to the Apple 
Watch, and it had low variance compared to their reference standard Actigraph GT3X.13 
Veerabhadrappa et al. showed that compared to manual step count, the Apple Watch had 
an overall minimal under-estimation of step count, about 1 step mean-level difference.14 
Xie et al. have also demonstrated that compared to manual measurements, the mean error 
for heart rate, number of steps, and distance were minimal.15 There are several WAMs 
available commercially; however, to widen the relevance of our study, we will be using 
the Apple Watch® (Apple Inc.), which is one of the most widely available wearable 
devices, and most recently was reported to have a global market share of 51 percent.16 
 
WAMs in patients with spine disease 
Few studies exist in the literature evaluating WAMs for spine patients, with small number 
of patients per study. In a case report using Fitbit, Phan and Mobbs showed that a patient 
who underwent minimally invasive lumbar fusion had initial decrease in step count and 
distance traveled but after 2 months post op, the patient improved in both categories.11 
This improvement was sustained at 12-month post op follow up (end point of study). In a 
prospective study of 30 patients undergoing spine surgery who were asked to wear 
Fitbits, Mobbs et al. showed improvement in steps taken and distance traveled at the 3-
month post op visit. Participants also noted improvement in PROMs. Two patients did 

July 31, 2024 
 
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not wear the device, and there were no comparison groups.11 Interestingly, Mobbs et al. 
did not find a correlation between objective activity levels and subjective PROMS, 
although their study was limited by its small size. 
 
Ours will be the first prospective, controlled clinical trial of a long-term outcome 
assessment of supplementing postoperative care of spine patients with commercially 
available WAMs. 
 
1. 
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 journal 2017;7:213-9. 
2. 
Davis H. Increasing rates of cervical and lumbar spine surgery in the United 
States, 1979-1990. Spine 1994;19:1117-23; discussion 23-4. 
3. 
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;77 Suppl 4:S136-41. 
4. 
2017 Profile of Older Americans. 2017. (Accessed 05/31/2019, 2019, at 
https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20A 
merica/2017OlderAmericansProfile.pdf.) 
5. 
Parker SL, Chotai S, Devin CJ, et al. Bending the Cost Curve-Establishing Value 
in Spine Surgery. Neurosurgery 2017;80:S61-s9. 
6. 
Epstein NE. A review article on the benefits of early mobilization following 
spinal surgery and other medical/surgical procedures. Surgical neurology international 
2014;5:S66-73. 
7. 
Guzman JZ, Cutler HS, Connolly J, et al. Patient-Reported Outcome Instruments 
in Spine Surgery. Spine 2016;41:429-37. 
8. 
Lu TC, Fu CM, Ma MH, Fang CC, Turner AM. Healthcare Applications of 
Smart Watches. A Systematic Review. Applied clinical informatics 2016;7:850-69. 
9. 
Reeder B, David A. Health at hand: A systematic review of smart watch uses for 
health and wellness. Journal of Biomedical Informatics 2016;63:269-76. 
10. 
Henriksen A, Haugen Mikalsen M, Woldaregay AZ, et al. Using Fitness Trackers 
and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer 
Wrist-Worn Wearables. Journal of medical Internet research 2018;20:e110. 
11. 
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 journal 2016;6:459-64. 
12. 
Phan K, Mobbs RJ. Long-Term Objective Physical Activity Measurements using 
a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody 
Fusion Surgery. Asian spine journal 2016;10:366-9. 
13. 
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; 
24;3(2). 
14. 
Veerabhadrappa P, Rhudy MB, Moran MD, Renninger MD, Dreisbach SB, Gift 
KM. Apple Watch Steps. J Gen Intern Med 2019; 34(1):14. 

July 31, 2024 
 
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15. 
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, 12;6(4). 
16. 
Global Smartwatch Vendor Market Share by Region: Q4 2018. Strategy 
Analytics, 2019. (Accessed 06/01/2019, 2019, at 
https://www.strategyanalytics.com/access-services/devices/wearables/market-data/report-
detail/global-smartwatch-vendor-market-share-by-region-q4-2018.) 
b. 
Findings from Past Animal Experiments 
Not applicable 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
Cohort 1: 
(I) 
around 200 patients total at Stanford Neuroscience Health Center and at Stanford 
Medicine Orthopaedic Spine Center 
(II) 
around 200 patients total at Stanford Neuroscience Health Center and at Stanford 
Medicine Orthopaedic Spine Center (the cohort will not include participants from any 
other non-Stanford sites) 
 
100 patients will be in the control arm - no Apple Watch or app; 100 patients will be in 
the intervention arm - will receive Apple Watch and will download app.  
 
A few additional subjects may be enrolled so as not to delay the completion of the trial. 
Surgery for a subject may change to several weeks later or subjects may decide not to do 
surgery. The target in each cohort will remain at about 100 subjects.  
 
Participants will be adults (greater than or equal to 18 years old) who will be undergoing 
elective spine surgery at Stanford University Hospital by a Stanford Neurosurgery or 
Orthopaedic Spine attending physician. The reason for using such participants is to be 
able to effectively assess long-term mobility and satisfaction outcomes of patients who 
have undergone spine surgery who will be using Apple Watch in addition to the standard 
of care. 
 
Cohort 2:  
(I) 15 patients total at Stanford Neuroscience Health Center 
(II) 15 patients total at Stanford Neuroscience Health Center (the cohort will not include 
participants from any other sites) 
 
Participants will be adults (greater than or equal to 18 years old) who are undergoing any 
back treatment by a Stanford Neurosurgery attending physician. The reason for using 
such participants is to be able to effectively assess short-term mobility and satisfaction 
outcomes of patients experiencing back pain who will be using Apple Watch in addition 
to the standard of care. 

July 31, 2024 
 
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b. 
Age, Gender, and Ethnic Background 
All participants will be adults (greater than or equal to 18 years old). There is no other 
specification in terms of gender or ethnic background. 
c. 
Vulnerable Populations 
Vulnerable subjects are not being selectively recruited for this study. Due to the study 
design, children and decisionally impaired individuals will be excluded from our study. It 
is possible that other types of vulnerable individuals would be included though not 
through targeting/solicitation (pregnant women, economically or educationally 
disadvantaged, homeless people, employees, and students). We will ensure that these 
individuals understand the voluntariness of the study and will assess that overall benefits 
outweigh risks of participation. All participants will be provided phone number and email 
address for the study coordinator whom they can contact at any point with any issues that 
may arise. If at any point the risks become greater and/or patients indicate no longer 
wanting to participate, we will take steps to ensure each individual’s rights and welfare 
first and, if appropriate, discontinue their participation in the study. We will communicate 
with the IRB immediately about any issues that arise in regards to the vulnerable 
individuals. 
d. 
Rationale for Exclusion of Certain Populations 
Children are not included for several reasons. First, assessment of behavioral 
modification using WAM postoperatively in spine patients has not been studied via a trial 
in any population. We need to establish an understanding with an adult population first to 
better understand the full scope of risks and benefits before considering exposing children 
to the potential risks of this type of study. Second, a better assessment of commercially 
available WAMs use amongst children is needed to understand applicability of this 
research question to pediatric spine patients. Lastly, the neurosurgery faculty in this study 
operate primarily on adult patients, who have a much higher prevalence of spine disease 
than the pediatric population. 
e. 
Stanford Populations 
These populations are not being targeted by our study; however, it is possible that they 
will be recruited into the study if they meet eligibility criteria. We estimate that less than 
10 percent of enrolled patients will be lab personnel, employees, and/or students. 
f. 
Healthy Volunteers 
All participants will have a spine pathology for which they will undergo surgery for 
Cohort 1 or back pain for which they will undergo standard treatment for Cohort 2. 
Healthy volunteers are not targeted for this study.  
 
The primary risk to patients with their involvement in this study is an accidental privacy 
breach. As we describe in other sections, all data will be collected and stored on 
password-protected, encrypted computers. Apple will not have access to any of the 
patient specific health information. The patient’s Apple Watch metrics (such as steps 

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traveled, HR, etc.) are all available on the iCloud for the patient only, not to Apple. We 
will ensure that only IRB-approved personnel have access to the patient-identifiable data. 
g. 
Recruitment Details 
Participants will be identified via referral from the treating surgeon in the Neurosurgery 
Department (Drs. Corinna Zygourakis, Atman Desai, Anand Veeravagu, Jon Park, 
Lawrence Shuer, and John Ratliff) or Orthopaedic Spine Department (Drs. Todd Alamin, 
Serena Hu, Kirkham Wood).  
 
The patient will either be initially informed about the study by someone who is involved 
in the study and who he/she has a treating relationship with (e.g., in cases where patient is 
being treated by Dr. Zygourakis or Dr. Desai) OR the patient’s physician will obtain 
approval from the patient to be contacted by the study team (e.g., in cases where the 
patient is being treated by another spine surgeon in our department). 
 
Recruitment material will be distributed to treating physicians. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
Cohort 1: 
Adults (equal to or greater than 18 years old); scheduled to undergo elective spine 
surgery at Stanford University Hospital by a treating surgeon in the Neurosurgery 
Department (Drs. Corinna Zygourakis, Atman Desai, Anand Veeravagu, Jon Park, 
John Ratliff, and Lawrence Shuer) or Orthopaedic Spine Department (Drs. Todd 
Alamin, Serena Hu, Kirkham Wood); anticipated to have clinic follow up for a period 
of at least 12 months postoperatively. 
 
Cohort 2: 
Adults (equal to or greater than 18 years old); undergoing any back treatment at 
Stanford University by a treating surgeon in the Neurosurgery Department (Drs. 
Corinna Zygourakis, Atman Desai, Anand Veeravagu, Jon Park, John Ratliff, and 
Lawrence Shuer). 
ii. 
Exclusion Criteria 
For Cohort 1, we will exclude patients undergoing spine surgery for trauma, tumors, 
or infectious disease.  
 
For Cohort 1 and Cohort 2, we will exclude patients who do not speak English 
because iPhone app, surveys and Apple Watch data is in English. 
i. 
Screening Procedures 
Screening for eligibility will be conducted in the clinic. Patients who are scheduled for 
pre-operative visits and meet inclusion criteria will be eligible for enrollment. Each 
patient’s attending surgeon will give the referral to approach each patient for recruitment 
into the study. 

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j. 
Participation in Multiple Protocols 
It is unlikely that patients will be involved in another research study, as there are no other 
prospective studies that are currently enrolling spine patients in the Stanford 
Neuroscience Health Center. We have contacted other spine faculty in the Neurosurgery 
Department and none have identified any trials that participants might be enrolled in 
during our study period. There are retrospective reviews which do not require patient 
enrollment. 
k. 
Payments to Participants 
Cohort 1: 
If patients in the interventional group are asked to come for an extra clinic visit for 
training and setup, they will receive a parking pass for the visits. 
 
For patients in the control group (100 patients), we will compensate their time for 
completing questionnaires (these patients will not be provided an Apple Watch during the 
study). At each visit during which questionnaires are completed, the participant will 
receive 
, for a possible total of 
 for the entirety of the study. 
 
Cohort 2: 
Patients will be given an Apple Watch and charging cable free of charge. This must be 
returned to Stanford at the end of the study period. If you are asked to come for an extra 
clinic visit for training and setup, you will receive a parking pass for the visits. 
l. 
Costs to Participants 
Not applicable. 
m. 
Planned Duration of the Study 
(i) 
Spring 2020: Obtain IRB approval for revised protocol; June 1, 2020 - May 31, 
2023: Screen and enroll new patients;  
(ii) 
Duration of active participation in study: approximately 12 months 
(iii) 
June 1, 2020 - May 31, 2024: Continue collecting data, complete at least 6-month 
follow-up on all patients and perform interval analysis; June 1 - August 31, 2024: final 
data analysis. 
5. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
The device being used is a commercially available wearable technology (the Apple 
Watch); it has not been shown to have association with any significant risk to the user.  
ii. 
Investigational drugs 
Not applicable 
iii. 
Commercially available drugs, biologics, reagents or chemicals 

July 31, 2024 
 
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Not applicable 
iv. 
Procedures 
The study does not include any investigational procedures. For Cohort 1, patients will be 
using the Apple Watch daily for 2-6 weeks prior to their spine surgery and for 12 months 
following surgery. For Cohort 2, patients will be using the Apple Watch daily for 2-3 
weeks. The entirety of the clinical care that patients will be outside the purview of this 
study. 
v. 
Radioisotopes/radiation-producing machines 
Not applicable 
vi. 
Physical well-being 
The Apple Watch has not been linked to any adverse physical health effects. 
vii. 
Psychological well-being 
The device will give patients feedback on their activity. This may have positive and 
motivating impact on patients; however, we acknowledge that it may also negative 
psychological effects. The degree of the latter risk is unknown and will be monitored 
throughout the trial, so that it may be addressed. At each time point, patients fill out the 
health-related quality of life questionnaires that address aspects of anxiety and 
depression, so we can assess whether the Apple Watch itself is having a detrimental 
effect on our patients. 
viii. 
Economic well-being 
Not applicable 
ix. 
Social well-being 
Not applicable 
x. 
Overall evaluation of risk 
Low 
b. 
International Research Risk Procedures 
Not applicable 
c. 
Procedures to Minimize Risk 
For Cohort 1, we will check in with patients throughout the study period in person (4-6 
weeks, 3 months, 6 months, and 12 months post-operatively); these check-in meetings 
will include detecting any negative effects of the study on the patient. Any unexpected 
hazards will be reported to the IRB, and the patient will be removed from the study. 
 
For Cohort 2, the study is only 2-3 weeks; however, participants will be able to contact 
study coordinator at any point to report any negative effects of the study on the patient. 

July 31, 2024 
 
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Any unexpected hazards will be reported to the IRB, and the patient will be removed 
from the study. 
 
The greatest risk to patients in this study will be confidentiality of identifiable 
information. All electronic devices (e.g., computers, hard drives, thumb drives, etc.) that 
contain identifiable patient information will meet Stanford School of Medicine security 
standards; additionally, the devices will be password-protected and encrypted. The 
patient’s activity data will be downloaded to Stanford Research IT-approved Google 
Firebase storage. All data will be stored per approved Research IT / DRA protocol. No 
data will be shared with industry partner providing part of the funding. 
d. 
Study Conclusion 
For Cohort 1, as participants reach the 12-month study period, we will conduct ongoing 
analysis of the data. If we observe clear statistically significant and clinically significant 
superiority in one group, the study will be terminated prior to the projected total 
participant population has been enrolled. If there are no such differences noted, the study 
will terminate after the all patients have had their 12-month postoperative visit, likely 
June 2022. We do not expect adverse effects but will be able to identify them at 
postoperative visits (4-6 weeks, 3 months, 6 months, and 12 months post-operatively) and 
intervene if needed. 
 
For Cohort 2, we will conduct ongoing analysis of the data. If we observe clear 
statistically significant and clinically significant changes, the study will be terminated 
prior to the projected total participant population has been enrolled. If there are no such 
differences noted, the Cohort 2 will terminate after all patients have completed the study, 
likely August 2021. 
6. 
BENEFITS 
We posit that patients with spine pathology who undergo surgery or are experiencing back pain 
will improve their physical activity level and feel more satisfied with their quality of life when 
wearable activity monitors are used to provide feedback on physical activity and when such data 
is used to initiate discussions about activity with their spine surgeon. Our hope is that using a 
commercially available device will make the results of our study applicable to future patients who 
may also have the Apple Watch (or other commercially available activity monitors). 
7. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.