Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
Phase: NA
Conditions: Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion, Meniscus Tear, Tibial, Atrophy, Muscular
Sponsor: University of California, San Francisco

Study Protocol and Analysis Plan 
 
Title: Blood Flow Restriction after Meniscus Repair 
 
Document Date: 10/25/2023 
 
NCT04436523 
Protocol ID: 19-29641 
 

Study Application (Version 1.10)
1.0
General Information
*Enter the full title of your study:
Comparison of outcomes utilizing blood flow restriction training as a rehabilitative protocol in 
post-operative meniscus repair patients
 
 
*Enter the study alias:
Blood flow restriction training in orthopaedic knee conditions
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 and Specify Research Location:
Is 
Primary? Department Name
UCSF - 
 - PHYSICAL THERAPY
777050
UCSF - 
 - M_Ortho-Admin-Core-Rsdnt Admin
139404
UCSF - 
 - M_Orthopaedic Surgery
139400
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Lansdown, Drew MD, MD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Arriaga-Martinez, Ivan 
 Co-Principal Investigator
Chiu, Jonathan V 
 Other Investigator
Cole, Elliott W 
 Other Investigator
N

Colyvas, Nicholas 
 Other Investigator
Edwards, Sara 
 Other Investigator
Feeley, Brian T MD, MD 
 Co-Principal Investigator
Freitas, Nina 
 Other Investigator
Laroque, Elly S 
 Other Investigator
Ma, C. Benjamin MD, MD 
 Other Investigator
Theismann, Jeffrey 
 Other Investigator
Wang, Kevin 
 Other Investigator
Wong, Stephanie E MD, MD 
 Other Investigator
Zhang, Alan L, MD 
 Other Investigator
B) Research Support Staff
Carpio, Jocelyn G 
 Study Coordinator
Sampson, Hayden 
 Study Coordinator
3.3 *Please add a Study Contact
 
Carpio, Jocelyn G 
Lansdown, Drew MD, MD 
Sampson, Hayden 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions 
Updated January 2019 - Revised Common Rule (January 2018) Compliant - v92
4.1  * 
:
PROJECT SUMMARY  (REQUIRED) Give a brief overview of this project (250 words or less). Tell us 

what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
 
Abstract, paste it here (Click on the orange question mark to the right for more detailed instructions):
 
It is important to study innovative ways to enhance the rehabilitation of orthopaedic patients to 
optimally restore patient function. Blood flow restriction (BFR) is a training tool that has been 
shown to be useful in the rehabilitative setting, but its effectiveness in treating patients with 
orthopaedic knee conditions requires further investigation. This study therefore seeks to 
understand whether BFR is a useful rehabilitation tool across various populations with 
musculoskeletal knee conditions. BFR is a unique and promising strategy for patients who cannot 
tolerate high-load resistance training, as it can be combined with with low-load exercises during 
rehabilitation to optimize muscle strength and hypertrophy. Patients that may benefit most from 
this are post-operative knee patients during early phases, including those that may have 
weightbearing restrictions, and patients with orthopaedic knee joint conditions with impaired load-
tolerance. These patients must often limit physical activities due to post-operative surgical 
precautions or pain, which results in poorer patient outcomes, including muscular atrophy, 
increased risk of injury, and delayed return to activity/sports. This study will help clarify whether 
BFR can reduce these complications through improvements in strength, muscle size, and function 
in patients with orthopaedic knee conditions. If successful, this concept could be applied across 
other surgeries and disciplines within orthopaedics.
4.2  
 
* 
:
HUD DEVICE (REQUIRED) 
 
Does this application involve a Humanitarian Use Device (HUD):
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  * 
: 
TYPE OF RESEARCH (REQUIRED) 
(
Select the option that best fits your project Click the orange 
question mark to the right for definitions and guidance):
Biomedical research (including medical records review, biospecimen collection and/or use, 
other healthcare or health outcomes related activities, research database, biospecimen bank, 
or recruitment registry) 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is 
mainly social/behavioral but also involves specimen collection or blood draws to look at 
biological measures) 
4.4  * 
 
SUBJECT CONTACT: (REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
 
* RISK LEVEL: (REQUIRED) What is your estimation of the risk level, including all screening 
:
procedures and study activities
Minimal risk 
Greater than minimal risk 
4.6  * REVIEW LEVEL: (REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 

Generally, only 
studies require 
Greater than Minimal Risk 
Full 
. 
Committee Review We suggest you check 
 
Expedited Review
instead or change the risk level, if you checked the wrong box.
4.9  
 
* DATA/SPECIMEN ANALYSIS ONLY: (REQUIRED) Does this study 
 involve records review and
ONLY
/or biospecimen analysis (do not check 'Yes' if this is a registry, research or recruitment database, or 
biospecimen repository):
  Yes  
  No
4.10  
 
* CLINICAL TRIAL: (REQUIRED)
 
Is this a clinical trial:   
According to The World Health Organization (WHO) and the 
International Committee of Medical Journal Editors (ICMJE) a 
clinical trial is:
Any research study that prospectively assigns human participants or 
groups of humans to one or more health-related interventions to 
evaluate the effects on health outcomes.
ICMJE requires 
 of a clinical trial in a public database (such as 
registration
ClinicalTrials.gov) prior to enrollment, for eventual publication of results in 
member biomedical journals.
Public Law 110-85 requires that all investigators who perform 
Guidance: 
an 
 must ensure that the trial is registered on a 
applicable clinical trial
 
.
government web site called ClinicalTrials.gov
 
The FDA requires registration for 'applicable clinical trials,' defined 
as follows:
For any trials of drugs and biologics: controlled clinical investigations, 
other than Phase 1 investigations, of a product subject to FDA 
regulation.
For trials of biomedical devices: controlled trials with health outcomes 
of devices subject to FDA regulation, other than small feasibility 
studies, and pediatric post-market surveillance.
 
 
For additional information on the ClinicalTrials.gov registration process at 
UCSF and the definition of a clinical trial for purposes of registration, visit 
 
the ClinicalTrials.gov section of the UCSF Clinical Research Resource 
HUB.
 
 
 Yes  
 No
 - 'NCT' number for this trial:
Clinical Trial Registration
Pending
4.11  * 
: 
CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s):
Phase 0
Phase 1

Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Not Applicable
4.12  
: 
* INVESTIGATOR-INITIATED (REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
 of the 
 to 
The UCSF IRB recommends use
Virtual Regulatory Binder
manage your study.
4.13  
 
*
 
CANCER: (REQUIRED) Does this study involve cancer (e.g., the study involves patients with cancer 
or at risk for cancer, including behavioral research, epidemiological research, public policy research, 
specimen analysis, and chart reviews):
  Yes  
  No
4.14  * 
 
RADIATION EXPOSURE: (REQUIRED) Does your protocol involve any radiation exposure to patients
/subjects 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-
EITHER
standard care OR 
research
guided biopsy, radiation therapy, or nuclear medicine including PET, MUGA or bone scans):
  Yes  
  No
4.15  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final IRB 
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
 
*
 
Which Department(s) provided review: (REQUIRED)
UCSF Department of Orthopaedic Surgery
4.16  
 
* STEM CELLS: (REQUIRED) 
 
Does this study involve human stem cells (including iPS cells and adult 
stem cells), gametes or embryos:
No 
Yes, and requires IRB and GESCR review 
Yes, and requires GESCR review, but NOT IRB review 
4.17  
 
 
*
 
FINANCIAL INTERESTS: (REQUIRED) Do you or any other responsible personnel (or the spouse, 
 
 
registered domestic partner and/or dependent children thereof) have financial interests related to 
 
this study:
  Yes  
  No

5.0
 Funding
5.1  
 
* FEDERAL FUNDING: (REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
  Yes  
  No
5.2  
 
* 
Is this project linked in any way to the Department of Defense (DoD):
DoD INVOLVEMENT: 
(REQUIRED)
  Yes  
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:
External Sponsors:
 
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution:
Contract 
Type:
Project 
Number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
No Sponsor has been added to this IRB Study
Other Funding Sources and Unfunded Research - Gift, Program, 
Departmental or other Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
 Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply):
UCSF AND AFFILIATED SITES
UCSF Benioff Children's Hospital Oakland (BCHO)
UCSF China Basin clinics and facilities
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Langley Porter Psychiatric Institute (LPPI)
UCSF Medical Center at Mission Bay (Benioff Children's Hospital, the Betty Irene Moore 
Women's Hospital, Bakar Cancer Hospital, or outpatient clinics)
UCSF Mount Zion
UCSF Parnassus (Moffitt-Long hospital, dental clinics or other outpatient clinics)
UCSF Other Sites (including Laurel Heights and all the other sites outside the main hospitals)
Zuckerberg San Francisco General (ZSFG)
SF VA Medical Center (SF VAMC)
Fresno - UCSF Fresno OR Community Medical Center (CMC)
Gladstone
Institute on Aging (IOA)

Jewish Home
SF Dept of Public Health (DPH)
Vitalant (formerly Blood Centers of the Pacific and Blood Systems Research Institute)
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
UCSF Orthopaedic Institute in Mission Bay - Outpatient clinics and ambulatory surgery center
UCSF Orthopaedic Institute in Mission Bay - Physical Therapy
UCSF Medical Center at Mount Zion - Physical Therapy
 
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
  Yes  
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 
 units or utilize 
:
Services (CRS)
CRS services
  Yes  
  No
6.6  * MULTI-CENTER TRIAL: (REQUIRED) Is this a multi-center or multi-site research trial:
By 
' we mean a study where the protocol is developed 
'multi-center trial
by an lead investigator, an industry sponsor, consortium, a disease-group, 
etc.,and multiple sites across the nation or in different countries participate 
in the trial. The local sites do not have any control over the design of the 
protocol.
  Yes  
  No
6.8  OTHER SITE TYPES: Check all the other types of sites not affiliated with UCSF with which you are 
cooperating or collaborating on this project:
Do NOT check any boxes below if this is a multi-center clinical 
trial, UCSF is just one of the sites, and neither UCSF nor one of its 
faculty-linked affiliates (SF VAMC, Gladstone, ZSFG) are the 
coordinating center.
Other UC Campus
Other institution
Other community-based site

Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.14  * RELYING ON AN EXTERNAL IRB: (REQUIRED) Does this application include a request to rely on an 
external IRB (a central IRB (other than the NCI CIRB) or an external IRB (other UC campus, 
commercial, or institutional):
  Yes  
  No
7.0
 Research Plan and Procedures
7.1  
Describe the hypothesis or what the study hopes to prove:
HYPOTHESIS: 
Blood flow restriction (BFR) training has the potential to increase muscle size and strength, which 
can be valuable in combating atrophy and weakness in patients after acute injury or in the post-
operative setting. BFR involves use of a tourniquet to occlude venous outflow while maintaining 
partial arterial inflow. As a result, this anaerobic environment stimulates muscular hypertrophy 
through a variety of local and systemic factors [1-3]. Exercise performed at lower loads, including 
at 20-50% loading of a 1-repetition maximum (1-RM), can promote similar hypertrophy to higher 
intensity training [4]. Studies are emerging on BFR, including a recent randomized controlled trial 
demonstrating benefits in muscular strength and size in both the ipsilateral limb undergoing BFR 
and the contralateral limb [5]. This method of training has also been shown to be safe and may 
even decrease risk of deep venous thrombosis [6, 7]. Several groups have applied BFR post-
operatively after anterior cruciate ligament reconstructions and patients with various 
 and have shown the 
 
orthopaedic knee conditions
potential to improve quadriceps atrophy 
 [5-11].
and strength 
Patients with orthopaedic knee conditions often undergo periods of restricted weightbearing, 
immobilization, and/or significant reductions in physical activities, which can lead to substantial 
amounts of quadricep atrophy [12,13]. Quadriceps force is important in maintaining appropriate 
loading mechanics, which impacts risk for further injury and osteoarthritis [14, 15]. Quadriceps 
weakness is well-documented in patients following knee surgery, including arthroscopic partial 
meniscectomy, and in patients with degenerative knee conditions. Those undergoing meniscal 
repair see even greater extents of thigh musculature atrophy compared to those undergoing 
meniscectomy only given the longer period of immobilization post-operatively used to allow for 
meniscal healing [12,13]. Studies, however, are limited in evaluating patients with orthopaedic 
knee conditions, including those following acute meniscus repair surgery, undergoing BFR. A BFR 
protocol could help offset thigh musculature atrophy and improve rehabilitation in patients with 
orthopaedic knee conditions.
We hypothesize that quadriceps extension force will be significantly higher in patients undergoing 
a 
 
rehabilitative protocol with BFR versus those undergoing standard rehabilitation.
7.2  
List the specific aims:
AIMS: 
Aim 1: Evaluate the force production and strength of the affected extremity after BFR 
compared to those in the standard rehabilitation control group.
Hypothesis 1: Force production, as measured by peak force determined via hand-held 
dynamometer at 30 and 90 degrees of knee flexion for quadriceps and hamstrings, will be 
 
significantly higher after rehabilitation with incorporation of BFR relative to patients without BFR.
We will evaluate previously described primary measures including peak quadriceps/knee 
extension force and limb circumferences [8-11, 16, 17]. Rating of perceived exertion (RPE) will be 
measured during testing to ensure the patients are meeting appropriate standards of effort (RPE 
goal 7-8). Measurements would be taken weekly for up to 10 weeks post-operatively during 
assigned physical therapy sessions; these weekly measurements will be taken by trained physical 
therapists at UCSF who are blinded to the patient's treatment group.

Aim 2: Compare performance on functional outcome measures relative to those in 
standard-of-care rehabilitative protocols and secondarily evaluate patient-reported 
outcomes.
Hypothesis 2: Functional outcome scores, as measured via standard scoring for single leg squat 
and Ybalance tests, as well as patient-reported outcomes measured via the International Knee 
 
Documentation Committee (IKDC) score will be higher in those patients undergoing BFR training 
 
relative to those undergoing standard therapy.
We will compare functional and patient-reported outcome measures between the two groups to 
ascertain if there are clinical outcome differences after blood flow restriction training. Functional 
milestones evaluated include single leg squat test, 3-hop test, and Y-balance test. Patient-
reported outcomes will be measured using the IKDC standard knee evaluation form at baseline 
and at the conclusion of the study period. By assessing the above aims, we seek to distinguish to 
see if BFR training helps mitigate quadriceps atrophy in patients with orthopaedic knee 
conditions. This readily available and non-invasive treatment may have the potential to greatly 
improve orthopaedic rehabilitation and limit the detrimental effects of post-operative atrophy and 
progressive muscular deconditioning. 
 
7.3  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
This study will have two parallel arms. The first one will be a double-blinded, single-
 of patients undergoing in-person rehabilitation 
institution, randomized controlled trial
following arthroscopic meniscus repair. The second will be a single blinded, single institution, 
 of patients undergoing in-person or telehealth rehabilitation of 
prospective clinical trial
orthopaedic knee conditions. In both arms, the study compare (1) a standard-of-care 
rehabilitation protocol versus (2) standard-of-care rehabilitation combined with BFR training with 
cuff occlusion applied to the affected extremity. All patients will be enrolled prospectively, prior to 
beginning rehabilitation. Patients with arthroscopic meniscus repair who are unable or choose not 
to participate in in-person rehabilitation will be allowed to undergo telehealth rehabilitation 
through the second arm of this study. 
Rehabilitative exercises would be advanced per the physical therapists’ discretion with similar 
exercises for patients in both groups for direct comparison. These exercises are part of an already-
established rehabilitation protocols that are in place, with the only difference being the addition of 
the BFR cuff in the intervention group. Patients would undergo their supervised rehabilitation for 
8-12 weeks.
 
7.4  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):
If this is a first in humans study, please summarize the safety data from 
the animal studies. For pediatric drug or device studies, please identify if 
this is the first study in pediatric populations.  
Muscular hypertrophy and strength are largely thought to be associated with recruitment of larger 
motor units associated with type II muscle fibers [3]. Because type II muscle fibers are recruited 
with higher intensities and contractile forces, it is thought that performing exercise at loading 
>65% of 1-RM has the largest effect on muscle mass and strength gains [18]. Blood flow 
restriction (BFR) training, however, may allow for similar hypertrophic and strength response 
while functioning at lower loading or mechanical tension [3, 4]. BFR training is increasing in 
popularity in commercial gyms, athletic training programs, rehabilitation, and research settings. 
This non-invasive treatment involves the use of a tourniquet system to restrict venous inflow 
while maintaining arterial outflow during exercise. A purported benefit is the relative increase in 
cross-sectional muscle area which corresponds to increased strength and power output [1-6, 8, 
10-11, 16-17]. Mechanistically, the benefits of BFR appear to stem from both local and systemic 
factors [1-3]. Metabolic stress induced by a relatively hypoxic environment under the tourniquet 

may increase systemic and localized hormones and increase cellular swelling [3]. Another benefit 
of BFR is that because the loading is less than that of higher-intensity training, which primarily 
affords its effect through high mechanical tension, there is less muscular damage and theorized 
quicker recovery from training [3]. 
Due to its benefits in improving size and strength at lower loading and with quick recovery, BFR is 
a potential avenue for patients with injuries or in the post-operative setting to counteract disuse 
atrophy without requiring high-load training. By applying BFR protocols to those undergoing 
meniscus repair surgery and recovering from other orthopaedic knee conditions, we can evaluate 
whether BFR training will improve size and strength of the thigh musculature and understand the 
impact of this treatment on functional and patient-reported outcomes. This would be beneficial to 
advising rehabilitation methods and clarifying the role BFR may have on accelerating recovery. 
7.5  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
In healthy patients, there have been demonstrated benefits in knee extension torque and cross-
sectional area, although inconsistencies in study protocols limit interpretation [5, 9, 10]. A 
randomized controlled trial has demonstrated that BFR can have benefits not just distal to the 
area of occlusion, but also proximally on the ipsilateral extremity and even on the contralateral 
extremity which may be attributable to the systemic benefits of the training [1-3, 5]. 
Orthopaedic studies to date have largely focused on BFR in patients undergoing anterior cruciate 
ligament reconstruction, as it is well-described that this group has significant quadriceps atrophy. 
Thus far these studies have proven to be safe and do demonstrate the possibility in reducing 
atrophy [5-11]. Studies, however, are limited in the population of patients undergoing 
arthroscopic meniscus repair and other orthopaedic knee conditions. Patients undergoing 
arthroscopic meniscal repair also have decreased quadriceps force production like those 
undergoing anterior cruciate ligament reconstructions which is exacerbated by a period of 
immobilization post-operatively [12,13]. Furthermore, patients with knee osteoarthritis have also 
been found to have increased quadriceps muscle atrophy [28]. This diminished strength 
contributes to poor loading mechanics, therefore increasing the risk of further injury and 
osteoarthritis [14, 15].
Therefore, it is of interest to pursue rehabilitative protocols aimed at improving strength in those 
with orthopaedic knee conditions, including arthroscopic meniscus repair, as it is important to 
discover if BFR can cause a clinical difference in those with perhaps less natural quadriceps 
atrophy than those undergoing anterior cruciate ligament surgery. One pilot study evaluated BFR 
after knee arthroscopy (including several heterogenous procedures) and demonstrated nearly two 
times increased extension strength compared to controls, hinting that benefits may not be just in 
those with as severe quadriceps atrophy as seen in anterior cruciate ligament injuries.
7.6  
Is this a treatment study, i.e. does this study intend to provide treatment 
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED)
 Yes  
 No
7.7  
 Does this study involve any procedures, lab tests or imaging studies that 
* BILLABLE PROCEDURES:
have a CPT code and could be billable to patients, their insurance, Medi-Cal, Medicare, or any other 
entity (answer 'Yes' even if the study is going to pay for all the procedures): (REQUIRED)
 Yes  
 No
7.8  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Social media-based research activities
Observation

Fitness tests or other exertion activities
Use of mobile health apps or other apps
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, 
etc.)
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Administration of contrast agent
Randomization to one intervention versus another
Use of placebo
Biopsy conducted solely for research purposes
Sham surgical procedure
None of the above
7.9  
PROCEDURES / METHODS: 
* 
(REQUIRED)
For clinical research, list all study procedures, tests and treatments 
required for this study, including when and how often they will be 
performed. If there are no clinical procedures, describe the research 
activities.
 
If some of the activities would occur even if the person were not in the 
study, as in the case of treatment or tests performed for diagnostic 
purposes, clearly differentiate between those activities that will be 
done solely for research purposes and those that are happening as 
part of routine care.
 
Examples may include:
additional scans outside standard clinical diagnosis or monitoring
additional biopsies to collect tissue for research
extra clinic visits
extra lab tests not required for clinical care
If you have a procedure table, attach it to the submission with your 
other study documents.
Patient selection:
Patients will be recruited for participation prior to beginning rehabilitation. We will include male 
and female patients with an age range of 18 to 60 years old. Patients will be recruited from the 
Sports Medicine division of the UCSF Department of Orthopaedic Surgery. There are 5 fellowship-
trained sports surgeons who will actively recruit patients for this study. Our group has had prior 
success in randomized controlled trials. Patients will be excluded if they have risk factors for 
venous thromboembolism, including cancer, currently on oral contraceptive medications, or prior 
history of thromboembolism. Additional exclusion diseases include sickle cell anemia, Diabetes 
Mellitus, and vascular disease for increased risk for vascular complications.
Post-operative physical therapy will be completed at one of two UCSF outpatient physical therapy 
locations or through telehealth with a UCSF physical therapist. There are at least four faculty 
physical therapists who will participate in this study, all of whom are board-certified orthopaedic 
clinical specialists and are familiar with BFR techniques.
Study design:
This study will have two parallel arms. The first one will be a double-blinded, single-
 of patients undergoing in-person rehabilitation 
institution, randomized controlled trial
following arthroscopic meniscus repair. The second will be a single blinded, single institution, 
 of patients undergoing in-person or telehealth rehabilitation of 
prospective clinical trial
orthopaedic knee conditions. In both arms, the study compare (1) a standard-of-care 

rehabilitation protocol versus (2) standard-of-care rehabilitation combined with BFR training with 
cuff occlusion applied to the affected extremity. All patients will be enrolled prospectively, prior to 
beginning rehabilitation. Patients with arthroscopic meniscus repair who are unable or choose not 
to participate in in-person rehabilitation will be allowed to undergo telehealth rehabilitation 
through the second arm of this study. Rehabilitative exercises would be advanced per the 
physical therapists’ discretion with similar exercises for patients in both groups for direct 
comparison. For patients undergoing meniscus repairs, these standardized post-operative 
protocols will include a period of non-weightbearing followed by a period of weightbearing as 
guided by the surgeon. Intra-operatively, or prior to the initiation of the rehabilitation, the 
following will be noted to guide future analysis: Outerbridge Scale of Cartilage Injury, the type of 
meniscus tear, type of repair, and the percentage of meniscus resected. Clinical records would be 
reviewed for clinical, operative, and imaging data.
: Evaluate the force production and strength of the affected extremity after BFR 
Aim 1
compared to those in the standard rehabilitation control group.
Hypothesis 1: Force production, as measured by peak force determined via hand-held 
dynamometer at 30 and 90 degrees of knee flexion for quadriceps and hamstrings, will be 
significantly higher after rehabilitation with incorporation of BFR relative to patients without BFR.
Rationale: If it is shown that BFR can improve strength and limit atrophy in patients with 
orthopaedic knee conditions, it will provide an avenue of rehabilitation for quicker recovery.
Approach:
The BFR protocol itself is guided by prior studies. While there has not been a consistent protocol 
used, several themes in the more recent studies remain constant and would be used. Tourniquet 
setting would be set to 80% of the extremity arterial limb occlusion pressure (LOP) recorded with 
the patient lying supine, which is similar to that of prior studies and therefore varies with a 
patient's personalized occlusion pressure [5, 11, 16].
Using the Delfi Personalized Tourniquet System during in-person, the exercises would be 
performed as guided by the physical therapist (Appendix 2). Subjects undergoing telehealth BFR 
rehabilitation will be given a SAGA BFR unit and various resistance bands to use through the 
duration of the study (Appendix 3). The telehealth subjects will be instructed on safe utilization of 
the SAGA BFR unit under direct supervision of a licensed physical therapist who is certified in 
BFR. Subject education will also emphasize that the SAGA BFR device should only be utilized with 
the parameters and exercises that are prescribed by the physical therapist. These specific 
exercises and parameters will be reviewed, modified when indicated, and written for the patient’s 
reference during each physical therapy session. Participants will also receive written instructions 
on properly operating the SAGA device for 
reference. Patients in the telehealth group would be expected to return the SAGA BFR device 
upon completion of their rehabilitation protocol.
The Delfi and SAGA BFR systems are readily available within the UCSF Physical Therapy 
department and both have the benefits of automatically calculating a patient’s specific LOP, 
having a pressure application and interval timer, and a reps indicator. Varying sizes of tourniquet 
are available with limb protection sleeves. The devices will be calibrated upon start-up of each 
session to ensure accurate measurement and proper instrument operation and allows for auto-
regulation of pressure. The devices come with both audio and visual safety alarms warning of 
under- or over-pressurization. There is no difference in risk profiles between the Delfi and SAGA 
BFR devices. Both devices are automatic pneumatic BFR systems that provide the greatest 
accuracy of personalized BFR pressures, constantly monitor for maintenance of pressure, allow for 
immediate pressure release, and are superior to manual and non-pneumatic BFR bands that are 
commonly utilized in both clinical practice and BFR research. 
For participants in both the control and BFR training groups, exercises performed in the 
rehabilitation protocol would progress as guided by patient function from contractile to 
bodyweight exercises to additional low-load resistance [5, 11, 16]. Exercises included and the 
specific in-person and telehealth rehabilitation protocols are noted in Appendix 2 and Appendix 3, 
respectively. 
The in-person rehabilitation control group will have a cuff applied but inflated to a value of 20-30 
mmHg, which will not occlude blood flow to the affected extremity. 
The rehabilitation protocol would be performed for a total of 8-12 weeks. Postoperative 
rehabilitation will be divided into a non-weightbearing and weightbearing/strength-building phase 
as guided by surgeon discretion after meniscus repair. Rehabilitation would begin within 3-7 days 
after meniscus repair. Of note, in the non- weightbearing phase, low-intensity neuromuscular 

electrical stimulation (NMES) will be combined with BFR [20].  Non-postoperative patients will be 
progressed through standardized exercises according to patient strength and tolerance at the 
discretion of the physical therapist, as outlined in Appendix 3.
For both the in-person and telehealth rehabilitation groups, 4 sets of 30-15-15-15 repetitions 
would be performed per exercise with 15-30s rest between sets while the cuff is inflated. 
Exercises will be progressive loaded per physical therapist discretion with a goal of an exercise 
intensity of 20-30% 1-RM with 30-45s rest between sets. Occlusion will be maintained throughout 
the inter-set rest time, but patients will be given non-occlusive rest between exercises if desired 
by the patient or as guided by the physical therapist between exercise demonstrations and set-
up. The reperfusion timer associated with the tourniquet system will ensure adequate reperfusion 
time between pressurization cycles. Postoperative patients will attend physical therapy sessions 
twice a week for the non-weightbearing period (typically up to six weeks) and once-to-twice a 
week during the weightbearing phase. Non-postoperative participants will meet with their physical 
therapist once-to-twice per week through the entire study period.  RPE would be evaluated to 
strive for a goal RPE of 7-8 during the rehabilitation session.
Measurements taken by trained physical therapists at UCSF (who are blinded to the patient's 
assigned study group) would be taken between weekly or less frequent intervals for patients 
undergoing telehealth rehabilitation. These would include peak quadriceps/knee extension force 
and hamstring force production at 30 and 90 deg of knee flexion, measured as standard with a 
hand-held dynamometer which is readily available in the physical therapy center. Limb 
circumferences of the thigh and leg would be taken at two distances: 1/3 and ½ proximal along 
the length from the tibial tuberosity to the greater trochanter. The circumferences each would be 
assessed with tape measure three times for averaging.
The rehabilitation protocols themselves are standard-of-care rehabilitation, guided by 
the surgeon/physician and the physical therapist, and would be unchanged aside from 
the intervention of the BFR cuff in the intervention group. These measurements are 
.
routinely taken by the physical therapists
Expected Outcomes: We expect to see increased strength measures and increased limb 
circumferences in the BFR rehabilitative protocol group relative to the standard-of-care group.
Aim 2: Compare performance on functional outcome measures relative to those in 
standard-of-care rehabilitative protocols and secondarily evaluate patient-reported 
outcomes.
Hypothesis 2: Functional outcome scores, as measured via standard scoring for single leg squat 
and Y-balance tests, as well as patient-reported outcomes measured via the International Knee 
Documentation Committee (IKDC) score will be higher in those patients undergoing BFR training 
relative to those undergoing standard therapy.
Rationale: By having a rigid physical therapy protocol with possibly increased quadricep strength 
secondary to BFR, we would expect better knee control and ability to complete functional testing 
to appropriate safe standard. Performing adequately on functional testing is critical to advise 
return to activity and sport. Patient-reported outcome measures are representations of patient 
perception, and it is important to understand patient perception of pain and function after the 
different rehabilitative protocols.
Approach: Standard functional milestones to be evaluated are: single leg squat test, 3-hop test, 
and Y-balance test. These tests are used routinely in the clinic to evaluate control of knee 
mechanics, proprioception, and balance. All of these are important functions to return to activity 
safely. These tests will be evaluated post-operatively at 6 weeks, 3 months, and 6 months. Rating 
of these tests will be performed by the surgeon in the clinic at the post-operative visits as has 
been previously described and on both the operative and non-operative extremities [21-24] and 
compared between groups using the associated scoring scales. These functional tests are a 
.
part of standard post-operative and orthopaedic evaluation
In addition to these functional measures, patient reported outcomes would be measured at each 
clinic follow-up visit via the International Knee Documentation Committee (IKDC) outcome score, 
which has been demonstrated to demonstrate higher performance on measurements in those 
with meniscal injuries compared to Knee Injury and Osteoarthritis Outcome Score (KOOS) and 
Western Ontario and McMaster Universities Arthritis Index (WOMAC) [25]. This evaluation is 
 
subdivided into sections for symptoms, sports activities, and function and would be available for 
sub-analysis. The IKDC survey will be administered at 6-week, 3-month, and 6-month after 
beginning rehabilitation. These IKDC surveys would be administered for research 
.
purposes and are not routinely used in post-operative or orthopaedic clinic visits

Expected Outcomes: We expect to see higher scores on functional measures in the BFR 
rehabilitation group compared to the standard of care group. Secondarily, we anticipate better 
IKDC outcome score in those undergoing BFR training compared to standard therapy.
 
In summary,
(1) Patient-reported outcomes (PROs) will be taken prior to, during, and after rehabilitation
(2) Strength and thigh circumference measures will be taken and if the subject may not tolerate 
strength testing on the injured side, we will use the contralateral uninjured leg as a baseline for 
strength
(3) Functional testing will 
 be performed when the surgeon, physician, or physical therapist 
not
determine the patient would be at risk for further injury due to pain, weakness, instability, etc.
7.10  
: To what extent, if any, do the planned research procedures differ 
STANDARD CLINICAL PRACTICE
from the care that people would otherwise receive at this institution or the study site if not being 
done locally:
 
The research procedure and protocol involves minimal change to standard clinical practice. The 
primary difference is that the intervention group would be performing the same exercises as the 
standard-of-care rehabilitation control group with the addition of the blood pressure cuff for blood 
flow restriction training applied to an occlusive pressure. For the in-person rehabilitation control 
group will have the cuff applied, but inflated only to 20-30 mmHg to not occlude blood flow. The 
International Knee Documentation Committeee (IKDC) survey is not routinely administered in our 
orthopaedic or physical therapy clinic visits, but would be administered to both groups as a 
measure of patient-reported outcomes.
7.11  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
The International Knee Documentation Committee (IKDC) survey will be administered to patients 
in both study arms at 6-week, 3-month, and 6-month clinic visits or electronically.
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after 
completing the study application. Published instruments should 
NOT be attached.
7.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.) for analysis under this protocol and/or storage for future 
research: (REQUIRED)
  Yes  
  No
7.13  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:
Power Analysis:
Aim 1 – Knee Extension
In a previously published study by Bowman et al., knee extension torque in this RCT’s BFR group 
increased by 11% +/- 13 and the knee extension torque in the control group increased by 3% 
+/- 9 [5]. Using this data, the effect size expected is 0.72. Utilizing a goal of 0.8 power, alpha 
0.05, and equal enrollment between groups, power analysis reveals a sample size goal of 50 
patients (25 per group) for patients following meniscus repairs and 25 patients with additional 
orthopaedic knee conditions. 

Aim 2 – Y-balance testing & IKDC
In Hughes et al. recent study comparing BFR to traditional heavy load resistance training in post-
surgery ACL patients, Y-balance testing was most similar in the anterior direction, with scores 
normalized to leg length 32.9 +/- 9.7 for the BFR group and 17.5 +/- 6.7 in the traditional group 
[26]. Using this data, the effect size expected is 2.23. Utilizing a goal of 0.8 power, alpha 0.05, 
and equal enrollment between groups, power analysis reveals a sample size goal of 8 patients (4 
per group) for Y-balance testing. For IKDC, overall mean difference in that paper was 35.63 +/- 
7.06 for the BFR group and 23.33 +/- 8.76 for the traditional group [26]. The effect size with this 
data is 1.54.  Utilizing a goal of 0.8 power, alpha 0.05, and equal enrollment between groups, 
power analysis reveals a sample size goal of 14 total patients for IKDC (7 per group). Of note, 
Irrgang et al. described the international knee documentation committee (IKDC) subjective knee 
form and determined the value for a true change in score of 9.0 points which was achieved in 
that study [27].
Overall, the power analysis is most limited by knee extension (75 total patients or 25 per group). 
To account for dropout, canceled surgeries, and patients who are unable to make all of their 
physical therapy visits, we aim to enroll 40% more, or a goal of 105 patients total (35 per 
.
group)
Statistical Analysis: 
Statistical analysis will be performed comparing groups utilizing non-normative distribution 
analyses after obtainment of data. The alpha value for significance will be set to 0.05. Confidence 
intervals will be established on mean strength measures and thigh circumferences. For functional 
measures and IKDC survey, average scores and standard deviations will be utilized.
7.14  
List only the 5-10 most relevant references (a separate bibliography can be attached 
REFERENCES: 
 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
Please see a full separate bibliography attached. Most relevant references are below:
Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. 
Proximal, distal, and contralateral effects of blood flow restriction training on the lower 
extremities: a randomized controlled trial. 
 (2019). 11(2):149-156. PMID: 
Sports Health
30638439
Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry 
CS, Noehren BW. Effect of blood flow restriction training on quadriceps muscle strength, 
morphology, physiology, and knee biomechanics before and after anterior cruciate 
ligament reconstruction: protocol for a randomized controlled trial. 
 (2019). 
Phys Ther
PMID: 30951598.
Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood flow 
restriction training after knee arthroscopy: a randomized controlled pilot study. Clin J 
 (2017). 27(3):245-252. PMID: 27749358.
Sports Med
O’Donnell K, Freedman KB, Tjoumakaris FP. Rehabilitation protocols after isolated 
meniscal repair: a systematic review. 
. 2017;45(7):1687-1697. PMID: 
Am J Sports Med
28256906.
DePhillipo NN, Kennedy MI, LaPrade RF. Blood flow restriction therapy after knee surgery: 
indications, safety, considerations, and postoperative protocol. 
 (2018). 7
Arthrosc Tech
(10):e1037-e1043. PMID: 30377584.
Lipker LA, Persinger CR, Michalko BS, Durall CJ. Blood flow restriction therapy versus 
standard care for reducing quadriceps atrophy after anterior cruciate ligament 
reconstruction. 
 (2018). doi: 10.1123/jsr.2018-0062.
J of Sport Rehabilitation
Natsume T, Ozaki H, Saito AI, Abe T, Naito H. Effects of electrostimulation with blood flow 
restriction on muscle size and strength. 
. 2015;47(12):2621-7. PMID: 
Med Sci Sports Exerc
26110693.
Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D. Comparing the effectiveness of 
blood flow restriction and traditional heavy load resistance training in the post-surgery 
rehabilitation of anterior cruciate ligament reconstruction patients: a UK National Health 
Service randomised controlled trial. 
. 2019:1-19.
Sports Medicine
 
8.0
 Drugs and Devices

8.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes  
  No
 
Note: This question is frequently answered incorrectly. If any drugs 
or biologics, approved or unapproved, are being administered under 
this protocol, you should check 'Yes' unless you are 
 sure 
absolutely
that NONE of the drugs are part of the research protocol. Tip: Ask 
the PI or the sponsor if you are not sure how to answer this 
question.
8.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
 Yes  
 No
8.4  
 
 Are you requesting a Non-Significant Risk (NSR) determination for an investigational device: 
* NSR:
  
(REQUIRED)  Note: an 
 is different from an Investigational Device Exemption 
NSR determination
(IDE). Check the Help link for more guidance on what types of devices can qualify for an NSR 
 
determination.
  Yes  
  No
8.5  
List the medical devices or in vitro diagnostics to be studied or used. In the device 
LIST THE DEVICES: 
details screen you will be asked questions such as:
Whether the device is FDA approved or investigational
Medicare device category
If the device will be provided at no cost
If an IDE is necessary, the IDE number, and who holds the IDE
Risk category of the device
FDA status of the device
Please see the 
 for more details about the use of devices in research, including the 
UCSF IRB website
  
Investigator Checklist for Significant Risk, Non-Significant Risk, and/or IDE Exempt Device Studies  
 If the sponsor’s protocol does not list the IDE number, you must submit 
Verification of IDE numbers:
documentation from the sponsor or FDA identifying the IDE number for this study. Attach this 
  
documentation in the Other Study Documents section of the Initial Review Submission Packet.  If 
you have any correspondence from the FDA or sponsor regarding this device, 
 
please attach it to the application.  
View 
Details
Device Name
Is the Device 
FDA Approved
Is this a new 
device or a new 
use of an already 
approved device
IDE Number
Delfi Personalized 
Tourniquet System 
Yes 
No 
 
Manufacturer/Supplier of 
Device
Delfi Medical Innovations Inc. 
Medicare Category
A
B
Where will the Devices Be 
Stored
UCSF Physical Therapy Centers 
Will Devices be supplied at no 
Cost
Yes 

Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
Yes 
Is this a new device or a new 
use of an already approved 
device
No  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE details
 
In the opinion of the sponsor, 
select the level of risk 
associated with this device
No Significant Risk  
SAGA Blood Flow 
Restriction Bands 
No 
Yes 
 
Manufacturer/Supplier of 
Device
SAGA Fitness 
Medicare Category
A
B
Where will the Devices Be 
Stored
UCSF Physical Therapy Clinics 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
No 
Is this a new device or a new 
use of an already approved 
device
Yes  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE details
 
In the opinion of the sponsor, 
select the level of risk 
associated with this device
No Significant Risk  
8.6  
Is this an expanded access or compassionate use protocol, meaning the 
* EXPANDED ACCESS: 
primary purpose is to diagnose, monitor or treat a patient's condition, rather than the collection of 
safety and efficacy data of the experimental agent: (REQUIRED) 
  Yes  
  No
9.0
 Sample Size and Eligibility Criteria
9.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 
105

 If there are multiple participant groups, indicate how many people will be 
in each group:
Our goal enrollment is 105 patients total (35 per group in the randomized control trial and 
.
an additional 35 for the non-randomized group)
9.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
Power Analysis:
Aim 1 – Knee Extension
In a previously published study by Bowman et al., knee extension torque in this RCT’s BFR group 
increased by 11% +/- 13 and the knee extension torque in the control group increased by 3% 
+/- 9 [5]. Using this data, the effect size expected is 0.72. Utilizing a goal of 0.8 power, alpha 
0.05, and equal enrollment between groups, power analysis reveals a sample size goal of 50 
patients (25 per group) for patients following meniscus repairs and 25 patients with additional 
orthopaedic knee conditions. 
Aim 2 – Y-balance testing & IKDC
In Hughes et al. recent study comparing BFR to traditional heavy load resistance training in post-
surgery ACL patients, Y-balance testing was most similar in the anterior direction, with scores 
normalized to leg length 32.9 +/- 9.7 for the BFR group and 17.5 +/- 6.7 in the traditional group 
[26]. Using this data, the effect size expected is 2.23. Utilizing a goal of 0.8 power, alpha 0.05, 
and equal enrollment between groups, power analysis reveals a sample size goal of 8 patients (4 
per group) for Y-balance testing. For IKDC, overall mean difference in that paper was 35.63 +/- 
7.06 for the BFR group and 23.33 +/- 8.76 for the traditional group [26]. The effect size with this 
data is 1.54.  Utilizing a goal of 0.8 power, alpha 0.05, and equal enrollment between groups, 
power analysis reveals a sample size goal of 14 total patients for IKDC (7 per group). Of note, 
Irrgang et al. described the international knee documentation committee (IKDC) subjective knee 
form and determined the value for a true change in score of 9.0 points which was achieved in 
that study [27].
Overall, the power analysis is most limited by knee extension (75 total patients or 25 per group). 
To account for dropout, canceled surgeries, and patients who are unable to make all of their 
physical therapy visits, we aim to enroll 40% more, or a goal of 105 patients total (35 per 
.
group)
9.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
9.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above

9.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Adult subjects unable to consent for themselves
Adult subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
9.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, providers, 
administrators, students, parents, family members, etc.):
Male and female patients, ages 18 to 60 years old, who are either: 1) undergoing arthroscopic 
meniscus repair of either the medial or lateral meniscus, or both. We will include all meniscus 
repair types (all-inside, inside-out, outside-in). 2) have an orthopedic knee condition, including 
but not limited to knee osteoarthritis, patellofemoral pain, and status post knee arthroscopy 
9.8  
 List any exclusion criteria (e.g. reasons why someone would not be included in 
EXCLUSION CRITERIA:
the study):
Patients will be excluded if they have risk factors for venous thromboembolism, including 
cancer, currently on oral contraceptive medications, or prior history of thromboembolism.
Additional exclusion diseases include sickle cell anemia, Diabetes Mellitus, and vascular 
disease for increased risk for vascular complications.
Increased risk for vascular complications will be listed as those with hereditary coagulopathies; or 
evidence of peripheral vascular disease on physical examination, including diminished pulses, skin 
changes, or history of lower extremity cramping pain with walking. History of venous 
thromboembolism will exclude a patient from the study.
9.9  
Do any study activities take place on any patient 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
care units including inpatient wards, peri- or post-operative care units, operating rooms, or in the 
 
Emergency Department at UCSF Health medical facilities: (REQUIRED)
 Yes  
 No
9.11  
Does your protocol or study involve any of the following patient related 
EMERGENCY DEPARTMENT: 
* 
activities in the emergency department (e.g. subject identification, recruitment, consent, blood 
draws, specimen retrieval, involvement of ED staff (nursing, tech, and/or physician), or any other ED 
based procedures): (REQUIRED)
 
  Yes  
  No
10.0
 Recruitment and Consent
10.1  
Is this a competitive enrollment clinical trial? By competitive 
* COMPETITIVE ENROLLMENT: 
enrollment, we mean that sites who do not enroll participants early may not get to participate at all: 
(REQUIRED)  

  Yes  
  No
10.2  
 
What kinds of methods will be used to identify potential 
* SUBJECT IDENTIFICATION METHODS: 
participants for recruitment (check all that apply): (REQUIRED)
Review of patients' conditions, history, test results, etc. (includes patients seen in clinic, 
scheduled for surgery, a procedure, imaging, or tests, or seen in the Emergency Department 
as well as searching through medical record data for possible cohort identification)
Already approved recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials 
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social 
media, presentation of the study at community events/media, etc.)
Online recruiting tool (describe below)
CTSI Recruitment Services unit
Posting on UCSF Clinical Trials, ClinicalTrials.gov or other publicly available clinical trial website
Other method (describe below)
* Provide details about the subject identification methods: (REQUIRED)
Subjects will be identified in the outpatient clinic setting at the UCSF Orthopaedic Institute by one 
of the staff surgeons/physicians. For the randomized cohort, patients will be identified after 
having an MRI-confirmed meniscus injury for which surgical management via repair is 
recommended. Participants would be identified pre-operatively at their pre-operative clinic visit 
via the inclusion criteria previously described. For the non-randomized cohort, surgeons
/physicians will identify patients with orthopedic knee conditions being referred to UCSF physical 
therapy. Screening of participants for exclusion criteria would be performed by both the treating 
surgeon and clinical research coordinator.
10.3  * SEARCHING OF MEDICAL RECORDS: (REQUIRED)
Whose patients are they:
Investigators' own patients or patients seen within the same practice
Patients not under the care of the investigators
How and by whom will records be accessed and searched (check all that 
apply):
Self-search in APeX or other medical records source
Self-search using UCSF's Research Cohort Selection Tool
CTSI Consultation Service Recruitment Services
UCSF Academic Research Services (ARS)
University of California Research Exchange (UC ReX)
Other method (describe below)
10.4  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
Eligibility for recruitment will be determined at surgeon/physician clinic visit after an MRI-
confirmed meniscus injury for which an arthroscopic meniscus repair surgery is recommended or 
prior to beginning orthopaedic physical therapy rehabilitation. Both the treating surgeon/physician 
and the research coordinator will confirm eligibility and that the patients meet the inclusion 
criteria and do not have any exclusion criteria. 
10.5  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)

Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
10.6  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
10.7  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
Fellowship-trained sports medicine physicians or orthopaedic surgeons working at the UCSF 
Orthopaedic Institute will be conducting the initial search for potential participants. These 
surgeons will identify patients as potential candidates who will require physical therapy 
rehabilitation after a planned meniscus repair surgery or patients who may benefit from physical 
therapy for their orthopaedic knee condition. Subjects will be approached in the clinic setting after 
explaining the diagnosis and offering the standard-of-care treatment. The trial will be explained 
by the treating physician or surgeon, including randomization into study arms when applicable. If 
the patient expresses interest in the trial, a research coordinator will visit with the patient during 
the clinic visit prior to surgery or rehabilitation to discuss the details of study enrollment. 
 
A Participant Information Sheet will be provided to participants by surgeons.
10.8  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a consent form at the end of the consent discussion (signed consent)
Provide online 'eConsent' using an E-Signature system
Click through a link in a survey or email after reading about the study and then complete the 
study online (electronic consent)
Be told about the study and be given a handout/information sheet and be asked if they agree 
to participate (verbal consent)
Complete the study activities and turn in materials, as in the case of a completed survey that 
is placed in a drop box or mailed to the study team (implied consent)
Not be able to provide consent and will have a family member consent for them, as in the 
case of a critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk 
research or greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior 
(waiver of consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent 
text in the Informed Consent Documents section of the Initial 
Review Submission Packet Form.

10.9  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)   We encourage researchers to review our 
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.
The trial will be explained by the treating surgeon including randomization into study arms when 
applicable. If the patient expresses interest in the trial, a research coordinator will visit with the 
patient prior to starting physical therapy rehabilitation to discuss the details of study enrollment 
and consent patients into the study. This would occur in the privacy of the clinic room with the 
patient. Emphasis will be on voluntary enrollment and consent documents will be provided to the 
patient. The patient will be offered time to ask questions and will also be given time to consider 
options if they have not decided by the end of the clinic visit; however, to be enrolled in the 
study, the patient will need to decide prior to starting physical therapy rehabilitation. Prior to 
signing the consent form, teach-back will be used to ensure patient comprehension of the study 
and its goals, and alternative options.
If the research coordinator and patient are not able to meet in person to discuss the study details 
and consent documents, they can do this remotely via phone or Zoom. The consent form, HIPAA 
form and California Bill of Rights will be sent through DocuSign and can be signed electronically 
by the patient.
 It is important that the people obtaining consent are qualified to do so. 
*
Briefly describe the training and experience these individuals have in 
obtaining informed consent: (REQUIRED)
CITI Human Subjects Protection training is completed by all study staff conducting consent 
conversations. All investigators have performed clinical studies both inside and outside of UCSF 
and all clinical research coordinators have experience with multiple consent processes and the 
UCSF IRB.
10.10  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)   Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider 
using the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining 
written or verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended 
questions about the nature of the study or the experimental treatment, the risks and benefits 
of participating, and the voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their 
understanding of the study purpose, procedures, risks and benefits, as well as the voluntary 
nature of participation (especially appropriate when the consent process happens online or 
through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another 
method to assess comprehension:
10.14  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
As is standard, there would be two physical therapy visits per week for minimum six weeks and 
up to twelve weeks as guided by the therapist. Each physical therapy visit is anticipated to take 
30 min. In total, physical therapy visits would therefore take 12 to 15 hours.
 

Post-operative visits would be as are standard and would occur at two weeks, six weeks, three 
months, and six months and would be expected to take 30 min per visit, for a total of 2 hours for 
post-operative visits with the surgeon.
Of note, this time would be comparable with a standard-of-care physical therapy 
program.
 
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.
10.15  
Is there a standard of care (SOC) or usual care that would be offered 
ALTERNATIVES: 
to prospective participants at UCSF (or the study site) if they did not participate in this research 
study:
 Yes  
 No
Describe the care that patients would ordinarily receive at the medical 
center if they did not participate in this study (provide details, assuming 
that some of the IRB members are not specialists in this field):
Patients would ordinarily receive the same surgery and/or physical therapy rehabilitation whether 
or not they are involved in the study. If not in the study, they would also undergo a similar set of 
exercises as guided by physical therapists and would have the same routine surgeon/physician 
clinic visits. Physical therapy visits would likely taper earlier if not involved in the study (Patients 
may decrease to once weekly visits earlier if progressing well with physical therapy). They would 
not have as many post-operative measures of strength, thigh circumference, or patient-reported 
outcomes if not a participant. The study adds the use of the blood flow restriction device in the 
intervention group in a formalized and randomized process for direct comparison; however, the 
use of this device is already occurring with our physical therapists in routine post-operative visits 
as well so patients not in the study may be exposed to the intervention in a less standardized 
fashion.
10.16  
Is the study drug or treatment available off-study:
OFF-STUDY TREATMENT: 
Yes 
No  
Not applicable 
11.0
 Waiver of Consent/Authorization for Recruitment 
Purposes
This section is required when medical records may be reviewed to 
determine eligibility for recruitment.
11.1  
Study personnel need to access 
* PRACTICABILITY OF OBTAINING CONSENT PRIOR TO ACCESS: 
protected health information (PHI) during the recruitment process and it is not practicable to obtain 
informed consent until potential subjects have been identified: (REQUIRED)
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no
11.2  
 
A waiver for screening of health records to identify potential subjects poses no 
* RISK TO PRIVACY: 
more than minimal risk to privacy for participants:
Yes 

If 
, a waiver of authorization can NOT be granted.
no
11.3  
Screening health records prior to obtaining consent will not adversely affect 
* RIGHTS/WELFARE: 
subjects' rights and welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
11.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* IDENTIFIERS: 
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
11.5  
 
Describe any health information that will be collected prior to obtaining 
* HEALTH INFORMATION: 
informed consent:
Past medical history and x-ray findings will need to be collected to ensure patients do not meet 
any exclusion criteria. Patients will be excluded if they have risk factors for venous 
thromboembolism, including cancer, currently on oral contraceptive medications, or prior history 
of thromboembolism. Additional exclusion diseases include sickle cell anemia, Diabetes Mellitus, 
and vascular disease for increased risk for vascular complications.
Note: HIPAA requires that you collect the minimum necessary.
11.6  
Describe your plan to destroy any identifiable data 
* DATA RETENTION/DESTRUCTION PLAN: 
collected to determine eligibility for recruitment. This should be done at the earliest opportunity. If 
you plan to retain identifiable recruitment data, provide the justification for doing so:
Identifiable data collected to determine eligibility for recruitment will be destroyed after 
participant enrollment has closed.
12.0
 Risks and Benefits
12.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:

For interventional studies, risk that the regimen may be more harmful or less effective than 
other available interventions
Risks associated with radiation exposure for imaging studies specifically for research purposes
Risks associated with the administration of contrast agent for imaging studies
Risks associated with withholding of treatment or discontinuation of current treatment (e.g., 
washout period is required by the study protocol)
For randomized, placebo-controlled trials, possible temporary or permanent health 
consequences from the deprivation of effective therapies during the placebo administration 
period
For studies involving a sham surgical procedure, the risk that participants may experience 
increased morbidity without the possibility of benefit
Risks associated with modification or extension of a surgical procedure primarily for research 
purposes (e.g. risks associated with prolonging anesthesia, time in the operating room, etc.)
Risk of pain or physical discomfort caused by the research intervention
Possible personal discomfort due to sensitive topics (stress, embarassment, trauma)
12.2  
Describe any anticipated risks and discomforts not listed above: 
RISKS: 
* 
(REQUIRED)
Patients may have difficulty tolerating the BFR training. Although prior studies do not report much 
patient discomfort, we aim for an RPE of 7-8. This may not be tolerable for all patients, and if it is 
not, it is important to note this when planning for a future rehabilitation protocol. We have 
accounted for potential patient dropout if patients later decide to decline the BFR protocol.
 
With meniscus injuries and with post-operative immobilization to protect surgical repair, patients 
may experience quadriceps atrophy. This is a normal result of immobilization and not related to 
the study intervention. The goal of the study intervention is to seek a way to minimize this risk 
using the BFR training.
 
Risks and side effects related to the blood flow restriction training include those which are:
Likely
Soreness during or after activity
Muscle fatigue
Less Likely 
Pain at the site of the blood pressure tourniquet/cuff
Rare but serious
Blood clots
Venous thromboembolism was an initial theoretical concern with blood flow restriction training. 
However, this method of training has also been shown to be safe and may even decrease risk of 
deep venous thrombosis [6, 7]. A recent systematic review evaluating adverse events after blood 
flow restriction training noted just one instance out of 322 patients included of upper extremity 
deep venous thrombosis in a patient for whom BFR was used to manage thoracic outlet 
syndrome; it is unclear if in this patient the thrombosis pre-existed or was a result of the BFR 
[28]. 
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation

Patients will be notified of their right to remove themselves from the study at any timepoint. The 
physical therapists administering the BFR protocol to the intervention arm will review with the 
patients prior to their physical therapy session that if they feel undue discomfort that they can 
notify the therapist who will cease the intervention. This is already a part of the routine practice 
of our physical therapists utilizing BFR.
 
With regards to the quadriceps atrophy that patients experience in the setting of meniscus injury 
and immobilization after meniscus repair surgery, physical therapy in general can help counter 
this risk. However, patients still will expect some atrophy and therefore the goal of the study is to 
evaluate a way to counteract this atrophy with BFR training.
 
The BFR devices themselves have both audio and visual alarms warning of under- or over-
pressurization of the blood pressure cuff that will be monitored by the physical therapist for 
safety of use.
 
Risk minimization plans for risks associated with BFR training:
Likely
Soreness during or after activity 
Muscle fatigue
For each of these risks, the patient will be informed of muscular soreness and muscle fatigue as 
may occur with exercise activity. The patient will be monitored and involved in a discussion with 
the physical therapist throughout the training to ensure the patient is able to tolerate muscle 
soreness. Patients will be advised on adequate hydration and fueling as would be important for 
recovery after routine exercise. 
Less Likely 
Pain at the site of the blood pressure tourniquet/cuff
For this risk, the patient will be asked about their rate of perceived exertion and their pain level 
throughout the physical therapy session. If the patient's pain level is high and they would like to 
cease activity, they will be informed to let the therapist know immediately and the regimen will 
be stopped. The therapist will be routinely asking the patient about their pain level while training.
Rare but serious
Blood clots
For this risk, the patient will be advised on the signs and symptoms of blood clots, for which 
patients are at increased risk in the post-surgical setting or in instances of immobilization. In 
arthroscopic procedures, no post-operative venous thromboembolism prophylaxis is 
recommended. The use of the blood pressure tourniquet system does not appear to significantly 
increase risk of blood clots, but the patient will be advised on signs and symptoms and evaluate 
for these at their post-operative clinical visits.
12.4  
Describe the resources in place to conduct this study in a way that assures protection 
RESOURCES: 
of the rights and welfare of participants:   These resources typically include appropriately trained 
and qualified personnel (in terms availability, number, expertise and experience), funding, space, 
  
equipment, and time to devote to study activities.  Depending on the nature of the research study, 
investigators should consider the proximity or availability of critical resources that may be essential 
to the safety and welfare of participants, such as
the proximity of an emergency facility for care of participant injury
availability of psychological support after participation
resources for participant communication, such as language translation services
All of the methods described are feasible with the current research group, orthopaedic practice, 
and physical therapy center. The surgeries and rehabilitative protocols are as standard for 
appropriate patient care and will be part of the insurance-covered physical therapy program.
Clinical
All surgeries would be performed at the UCSF Orthopaedic Institute. This is a high-volume 
orthopaedic outpatient center with currently up to four operating rooms running four days a 
week. The practice includes seven fellowship-trained orthopaedic sports surgeons. A review of 

case logs for the month of April 2019 demonstrated 11 meniscus repair surgeries over the four-
week course. Technical equipment to perform these surgeries is readily available and the 
surgeries are a routine part of the practice.
Two physical therapy centers are associated with the UCSF Orthopaedic Institute that would be 
available for patient use.
For any unanticipated events, the Orthopaedic Institute is approximately 0.7 miles from the UCSF 
Benioff Children's Hospital Emergency Room at Mission Bay and 1.8 miles from the Zuckerberg 
San Francisco General Hospital Emergency Room. On-site at the Orthopaedic Institute, there are 
highly trained surgeons and operative and perioperative nurses available.
Major Equipment 
The physical therapy centers include numerous trained physical therapists with training in the use 
of hand-held dynamometers to be used in torque measurements, and those devices are already 
on site. Currently the two Delfi Personalized Tourniquet Systems and four SAGA BFR Band 
Systems are available. At minimum there are currently four physical therapists available for the 
project who are trained in the use of the BFR systems. Standard physical therapy equipment 
including balls, bands, and foam rollers are available for use. The physical therapy department 
has NMES that is already being used on patients post-operatively that can be utilized during the 
non-weightbearing phase of training as previously mentioned.
12.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, 
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
12.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
Blood flow restriction training has been shown to carry few risks. This method of training has 
been shown to be safe and may even decrease risk of deep venous thrombosis [6, 7], which was 
previously thought to be a potential risk. The most recent protocols show the potential to 
decrease quadriceps atrophy [5-11], which could enhance patients' functional and satisfaction 
measures post-operatively after a period of non-weightbearing. If there is no benefit seen with 
the intervention, participants would expect to see a similar result to those without the 
intervention. However, in the intervention arm we anticipate positive results with improved 
quadriceps strength which may lend to better functional measures, patient-reported outcomes, 
and return to activity. 
13.0
 
Data and Safety Monitoring Plan
13.1  
DATA AND SAFETY MONITORING PLAN (DSMP): 
* 
(REQUIRED) Provide a summary of the DSMP:

All greater than minimal risk studies are required to provide a plan. 
Lack of an adequate plan is one of the most common reasons why 
IRB approval is delayed.
 
Instructions:
Describe the plan for monitoring data quality and participant safety. Key 
areas that should be included in the plan are:
An explanation of the plan to monitor data collection, study progress, 
and safety
A description of who will perform the monitoring and at what 
frequency (e.g., the PI only, a contract research organization, a Data 
and Safety Monitoring Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse 
events, breaches of confidentiality, unanticipated problems involving 
risk to participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the 
UCSF IRB, the study sponsor, and other appropriate entities
As appropriate:
A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study 
interventions
Data collection will be monitored by the clinical research coordinator. Data will be collected via a 
UCSF REDCap database which is HIPAA-compliant and secure. The research coordinator will be in 
charge of the database and blinded data will be presented to the researchers for data analysis 
and review. Study progress will be monitored by the research coordinator and the PI, including 
the total number of enrollees, surgical dates, and completion of physical therapy sessions and 
post-operative follow-up. Study progress will be monitored monthly at the UCSF Sports Medicine 
monthly research meeting.
 
In addition to data for the purposes of analysis (such as functional outcomes and measures taken 
in the physical therapy sessions), adverse events, unanticipated problems, and complications will 
be reviewed by the physical therapists, the PI, and the research coordinator. All of these 
complications will be reviewed immediately by the study group with immediate notification to the 
PI and clinical research coordinator.
 
Interim data analysis will be conducted once over 50% of the patients have been enrolled and 
completed their post-operative follow-up appointments including functional outcome scores.
 
Patients reserve the right to withdraw from the study at any time. Patients will be removed from 
the study intervention if they are unable to tolerate the discomfort or are unable to attend the 
appropriate number of physical therapy sessions. The study protocol will be re-evaluated at any 
time of adverse events or complications from the intervention and the study will be stopped if 
there are concerns for unanticipated risks.
13.2  
DATA AND SAFETY MONITORING BOARD (DSMB): 
* 
(REQUIRED) Will a Data and Safety Monitoring 
Board (DSMB) be established:
Yes 
No 
Guidelines
  A Data and Safety Monitoring Board (DSMB) or Data Monitoring 
Committee (DMC) is a formal, independent committee that is specifically 
established to conduct interim monitoring, oversight and analysis of study 
information and data to assure the continuing safety, efficacy, 

appropriateness, relevance, and integrity of the study.
   
  The UCSF IRB reserves the right to request a DSMB/DMC for any study. 
However, the following are factors that the IRB will consider when making 
this determination: 
There is a significant likelihood of a serious adverse event to subjects
The study is conducted at multiple sites and the level of risk is greater 
than minimal
The study generates data that are blinded or randomized
The study involves a large number of patients randomized to one of 
two or more interventions
A study for which the performance of an interim analysis is crucial for 
the protection of the subjects
First use in humans
First use in children
The study involves gene therapy, stem cell therapy, or other novel 
interventions for which long-term outcome data are not known or 
available
14.0
 Confidentiality, Privacy, and Data Security
14.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be 
called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added 
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
14.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
  Yes  
  No
14.3  
Could a breach of 
SIGNIFICANT CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
privacy or confidentiality result in any significant consequences to participants, such as criminal or 
civil liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
  Yes  
  No
14.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
14.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
  Yes  
  No

14.6  
Will this study obain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
  Yes  
  No
14.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
  Yes  
  No
14.9  
Study data will be: 
* HIPAA APPLICABILITY: 
(REQUIRED)
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service 
(THREDS) at SFGH
In addition to signing a consent form, each subject will have to sign 
 
the UCSF Research Subject Authorization Form (HIPAA Form). 
Upload the HIPAA Authorization Form in the Other Study 
Documents section of the Initial Review Submission Packet Form. 
Failure to have patients sign the HIPAA Authorization is one of the 
 Please call 
most common findings from QIU Routine Site Visits.
the IRB office at 415-476-1814 if you have questions about HIPAA 
research requirements.  
If derived from a medical record, identify source:
Epic Apex
14.10  
Check all identifiers that will be collected and included in the research records, 
IDENTIFIERS: 
* 
even temporarily: (REQUIRED)
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers

Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Could study records include 
 photos or images (even 'unidentifiable' 
* 
ANY
ones): (REQUIRED)
 Yes  
 No
14.11  
 
Will health information or other clinical data be accessed from UCSF Health, 
* PATIENT RECORDS: 
Benioff Children's Hospital Oakland, or Zuckerberg San Francisco General (ZSFG): (REQUIRED) 
 Yes  
 No
14.14  
Does the research require access to any of 
HIPAA - PERMISSION TO ACCESS SENSITIVE DATA: 
* 
the following types of health information from the medical record: (check all that apply) 
(REQUIRED) 
Drug or alcohol abuse, diagnosis or treatment
HIV/AIDS testing information
Genetic testing information
Mental health diagnosis or treatment
None of the above
14.18  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Electronic case report form systems (eCRFs), such as OnCore or sponsor-provided clinical trial 
management portal
UCSF ITS approved Web-based online survey tools: Qualtrics or RedCap
Other web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Text Messaging
Wearable devices
Audio/video recordings
Photographs
Paper-based (surveys, logs, diaries, etc.)
Other:
What online survey or computer assisted interview tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
Study sponsor
UCSF data center (including OnCore, RedCap, Qualtrics, and MyResearch)
UCSF encrypted server, workstation, or laptop residing outside of UCSF data center
Personal devices, such as laptops or tablets that are not owned or managed by UCSF
SF VAMC

Zuckerberg San Francisco General Hospital
Benioff Children's Hospital Oakland
Langley Porter Psychiatric Institution
Other UCSF affiliate clinic or location (specify below)
Cloud vendor such as Amazon Web Services (AWS), Salesforce, etc. (specify below)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
14.19  
 Will patient records reviewed under this approval be 
* ADDITION OF RECORDS TO A REGISTRY:
added to a research database, repository, or registry (either already existing or established under 
this protocol): (REQUIRED) 
  Yes  
  No
14.20  
During the lifecycle of data collection, transmission, and storage, will identifiable 
DATA SHARING: 
* 
 
information be shared with or be accessible to anyone outside of UCSF: (REQUIRED)
  Yes  
  No
15.0
 Financial Considerations
15.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)
  Yes  
  No
15.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
 Yes  
 No
Describe the costs that may be incurred by subjects or 3rd party payers as 
a result of participation:
Explain why it is appropriate to charge those costs to the subjects
ompare subjects’ costs to the charges 
If this is a therapeutic study, c
that would typically be associated with receiving care off-study (e.g. is 
it more expensive to participate in this study than to receive care off-
study?)
Subjects or their insurance will be charged for their outpatient clinic visits, surgery, and physical 
therapy visits. As these are patients already undergoing surgery or rehabilitation, all costs are 
standard-of-care and would be incurred whether patients were part of the study or not.
There are no additional costs associated with the use of the BFR device.
16.0
 Other Approvals and Registrations
16.1  
 
Does this study involve administration of vaccines 
* ADMINISTRATION OF RECOMBINANT DNA: 
produced using recombinant DNA technologies to human subjects 
: 
(Help Link added Aug '15)
(REQUIRED)
  Yes  
  No

16.2  
Does this study involve human gene therapy: 
* HUMAN GENE THERAPY: 
(REQUIRED) 
  Yes  
  No
16.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 
and/or authorization from the following regulatory committees: 
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
17.0
 Qualifications of Key Study Personnel and Affiliated 
Personnel
 
NEW: January 2019 - Affiliated personnel who do not 
need access to iRIS no longer need to get a UCSF ID. 
Instead, add them below in the Affiliated Personnel 
table below. 
17.1    
  
  
  
Qualifications of Key Study Personnel:
 
Instructions:
 
For UCSF Key Study Personnel (KSP)* listed in 
 select the KSP 
Section 3.0,
from the drop down list and add a description of their study responsibilities, 
qualifications and training. In study responsibilities, identify every individual 
who will be involved in the consent process. Under qualifications, please 
include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
NOTE: This information is required and your application will be 
 
considered incomplete without it. If this study involves invasive or 
risky procedures, or procedures requiring special training or 
certification, please identify who will be conducting these 
procedures and provide details about their qualifications and 
training. Click the orange question mark for more information and 
examples. 
 
Training Requirements: 
The IRB requires that all Key Study Personnel complete Human Subjects 
Protection Training through 
 prior to approval of a new study, or a 
CITI

modification in which KSP are being added. More information on the CITI 
training requirement can be found on our 
. 
website  
 
* Definition of Key Study Personnel and CITI Training Requirements (Nov, 
 UCSF Key Study Personnel include the Principal Investigator, other investigators 
2015):
and research personnel who are directly involved in conducting research with study 
participants or who are directly involved in using study participants’ identifiable private 
information during the course of the research. Key Personnel also include faculty mentors
/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical 
Fellows serving as PI on the IRB application.
   
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each 
person be doing on the study. 
If there are procedures 
requiring special expertise or 
certification, identify who will 
be carrying these out. Also 
identify who will be obtaining 
informed consent.
Qualifications, Licensure, and 
Training
Dr. Lansdown, Drew MD, 
MD
Principal Investigator - 
oversee study, study 
design, data analysis, 
clinic data obtainment, 
manuscript preparation; 
will be obtaining 
informed consent
Orthopaedic Surgeon, 
Assistant Professor, UCSF 
Dept of Orthopaedic 
Surgery - Sports 
Medicine; MD.
Dr. Feeley, Brian T MD, MD
Co-Principal Investigator 
- study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Professor in Residence; 
MD. Chief of Sports 
Medicine and Shoulder 
Service, UCSF Dept of 
Orthopaedic Surgery; MD.
Arriaga-Martinez, Ivan
Co-Principal Investigator 
- study design, data 
analysis, physical therapy 
data obtainment, 
manuscript preparation
Doctor of Physical 
Therapy; DPT.
Sampson, Hayden
Clinical Research 
Coordinator - review of 
protocols, consenting 
patients, administering of 
surveys, conducting 
patient follow-up, data 
management
Clinical Research 
Coordinator, UCSF Dept 
of Orthopaedic Surgery - 
Sports Medicine.
Dr. Ma, C. Benjamin MD, 
MD
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Professor in Residence; 
MD. Vice Chair of Adult 
Orthopaedic Clinical 
Operations, UCSF Dept of 
Orthopaedic Surgery; MD.
Other Investigator - 

Zhang, Alan L, MD
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Associate Professor, 
UCSF Dept of 
Orthopaedic Surgery - 
Sports Medicine; MD.
Carpio, Jocelyn G
Clinical Research 
Coordinator - review of 
protocols, consenting 
patients, administering of 
surveys, conducting 
patient follow-up, data 
management
Clinical Research 
Coordinator in the UCSF 
Dept of Orthopaedic 
Surgery - Sports 
Medicine.
Freitas, Nina
Other Investigator - 
study design, data 
analysis, physical therapy 
data obtainment, 
manuscript preparation
Doctor of Physical 
Therapy; DPT.
Laroque, Elly S
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Professor, UCSF Dept of 
Orthopaedic Surgery - 
Sports Medicine; MD.
Chiu, Jonathan V
Other Investigator - 
study design, data 
analysis, physical therapy 
data obtainment, 
manuscript preparation
Doctor of Physical 
Therapy; DPT and 
Orthopaedic Clinical 
Specialist (OCS).
Colyvas, Nicholas
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Professor, UCSF Dept of 
Orthopaedic Surgery - 
Sports Medicine; Director 
of the UCSF Meniscus 
Preservation Center; MD.
Dr. Wong, Stephanie E 
MD, MD
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Assistant Professor, UCSF 
Dept of Orthopaedic 
Surgery - Sports 
Medicine; MD.
Edwards, Sara
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Orthopaedic Surgeon, 
Associate Professor, 
UCSF Dept of 
Orthopaedic Surgery - 
Sports Medicine; MD.
Other Investigator - 

Cole, Elliott W
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Clinical Fellow, UCSF 
Dept of Orthopaedic 
Surgery - Sports 
Medicine; MD.
Theismann, Jeffrey
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Clinical Fellow, UCSF 
Dept of Orthopaedic 
Surgery - Sports 
Medicine; MD.
Wang, Kevin
Other Investigator - 
study design, data 
analysis, clinic data 
obtainment, manuscript 
preparation; will be 
obtaining informed 
consent
Clinical Fellow, UCSF 
Dept of Orthopaedic 
Surgery - Sports 
Medicine; MD.
17.2  Affiliated Personnel: 
Instructions:
 
This section is for personnel who are not listed in Section 3.0: Grant Key 
 because their names were not found in 
Personnel Access to the Study
the User Directory when 
 the iRIS Database and MyAccess directories 
both
were searched. Add any study personnel who fit 
 of the following criteria 
ALL
in the table below:
They meet the definition of Key Study Personnel (see above), and
They are associated with a UCSF-affiliated institution (e.g., VAMC, 
Gladstone, Institute on Aging, Vitalant, NCIRE, SFDPH, or ZSFG), and
They do 
 have a UCSF ID, 
not
and
They do 
 need access to the study application and other study 
not
materials in iRIS.
 in the 
Note: Attach a CITI Certificate for all persons listed below
Other 
 section of the 
Study Documents
Initial Review Submission Packet 
 after completing the 
.
Form
Study Application
 
Click the orange question mark icon to the right for more information on 
who to include and who not to include in this section.
 
Do 
 list personnel from outside sites/non-UCSF-affiliated institutions. 
not
Contacts for those sites (i.e. other institution, community-based site, 
foreign country, or Sovereign Native American nation) should be listed in 
the 
 section of the application.
Outside Sites
 
If there are no personnel on your study that meet the above 
criteria, leave this section blank.
 
Name
Institution
Telephone
E-mail
Role

No External Personnel has been added to this IRB Study
Please describe the study responsibilities and qualifications of each affiliated 
person listed above:
18.0
 End of Study Application
End of Study Application Form
 
:
To continue working on the Study Application
Click on the section you need to edit in the left-hand menu. Remember to save through 
the entire Study Application after making changes.
 
:
If you are done working on the Study Application
Before proceeding, please go back to Section 4.0 Initial Screening 
Important: 
Questions and 
 through the form to make sure all the relevant 
Save and Continue
sections and questions have been included. If you've changed any answers since you 
started, the branching may have changed. Your application will be incomplete and it will 
have to be returned for corrections. 
 
Once you are sure the form is complete, click 
. If this is a new 
Save and Continue
study, you will automatically enter the 
, 
Initial Review Submission Packet Form
where you can attach 
or other 
. Review the 
consent forms 
study documents
Initial 
 for a list of required attachments.
Review Submission Checklist
 
Answer all questions and attach all required documents to speed up your 
approval.
 
 
 
 
 
The UCSF IRB welcomes feedback about the IRB Study Application Form. Please click the link to 
answer a 
 about the application form.
survey