Long Head of the Biceps Subpectoral Tenodesis Anatomic vs. Traditional Tensioning Technique During Rotator Cuff Repair: A Randomized Prospective Trial
Phase: NA
Conditions: Biceps Tendon Disorder, Tendinosis, Rotator Cuff Injuries
Sponsor: Loyola University

Protocol Outline 
 
Protocol Title: Restoring the anatomic tension relationship of the long head of the biceps during 
tenodesis 
IRB #: 212671 
Protocol Version: 6 
Protocol Date:   August 13, 2024 
Principal Investigator: Dane Salazar, MD and Nickolas Garbis, MD 
Research Team: Robert Burnham Jr., MD, Katherine Baur, BS, Tyler Morad, BS, Amy 
Wozniak, MS, Amanda Spevacek, BA, Hassan Farooq, Marissa VanDeVeer, Joshua Anderson, 
MS, Krishin Shivdasani MPH, Andrew Chen MD, Amir Boubekri MD, Michael Scheidt MD, 
Thomas Stanila BS 
 
Abstract 
The long head of the biceps can be a source of anterior shoulder pain that is primarily 
due to inflammation or instability of the long head of the biceps (LHB) tendon . 
Patients that fail non-operative management become candidates for biceps tenotomy 
and tenodesis. Currently, there is no universal protocol or gold standard for how the 
LHB tendon is tensioned. At our institution, the LHB is tensioned based on individual 
surgeon feel for the correct tensioning. The purpose of this study is to conduct a 
randomized, single-blinded prospective study comparing patients of the current 
regimen of bicep tensioning vs. utilizing a standardized method of anatomically 
tensioning the LHB tendon. The primary aim of assessing change in the American 
Shoulder and Elbow Surgeon (ASES) scores from baseline to post-surgery between 
the control and intervention groups will be assessed using a student’s t-test. In 
addition, longitudinal mixed effects models will be used to estimate changes in ASES 
scores, over all time-points using a random effect for surgeon.  Other relevant patient 
characteristics such as age, sex, and Charlson score will be included to explore the 
adjusted relationship of the intervention and outcomes over time. A secondary aim of 
this study is to collect specific  measurements of the myotendinous junction of the 
LHB tendon to potentially establish if any characteristics predispose patients to 
developing pathology of the LHB tendon.  
 
I. 
Background and Significance/Preliminary Studies 
Pathology involving the long head of the biceps (LHB) tendon is an established 
source of upper extremity pain. Biceps tendon pathology is often associated with 
other primary shoulder pathologies including subacromial impingement, rotator cuff 
tears, or stenosis of the bicipital groove. The histological findings of the extra-
articular portion of the LHB tendon indicate that it undergoes a chronic, degenerative 
process much like other tendinopathies of the body, such as de Quervain’s 
tenosynovitis of the wrist. 
 
Management of bicipital tendinopathy, such as tendonitis, is generally treated with 
conservative measures first, which consists of activity modification, non-steroidal 
anti-inflammatory drugs, and corticosteroid injections. If the patient fails these 
modalities of treatment, then surgical intervention is considered [7]. There are 

multiple ways to perform the procedure and different techniques to perform the 
tenodesis. The procedure involves performing a tenotomy (cutting) the LHB at the 
junction between the tendon and the supraglenoid tubercle (origin of the biceps 
tendon). Tenodesis (or re-attachment of the tendon at a different site) is performed at 
some location within the intertubercular groove, but outside of the shoulder joint, 
using one of many forms of fixation either with an open or an arthroscopic approach. 
Post-operatively, some patients report persistent shoulder pain, biceps muscle fatigue, 
and bicipital groove tenderness. Scores on the American Shoulder & Elbow Surgeons 
(ASES), a functional validated scale, are often used to measure these outcomes. 
 
Clinically, it may be important to consider the site of tenodesis in order to restore 
tension similar to that of normal physiological function. To date, there is no gold 
standard for the site and level of tenodesis [1, 3, 4, 6]. The current method for fixation 
(tenodesis) of the LHB tendon after tenotomy is based on surgeon feel for appropriate 
tensioning within the bicipital groove. We hypothesize that anatomic tensioning of 
the LHB during tenodesis will provide improved patient outcomes in the form of 
reducing anterior shoulder pain, bicipital fatigue, bicipital groove tenderness, and 
ASES scores. 
 
Additionally, there are no current population studies on the anatomy of the LHB 
tendon and myotendinous junction. Specifically, detail regarding the myotendinous 
junction transitional zone has not been described [2, 4, 5], nor whether certain 
anatomical aspects of LHB tendon and myotendinous junction affect the rate of 
pathology of the LHB. This research project serves as a means to discover if these 
anatomical differences have clinical significance by obtaining measurements at the 
myotendinous junction of the LHB. 
 
II. 
Study Aims 
The main purpose of this study is to determine the clinical impact of restoring the 
anatomic-tension relationship of the long head of the biceps (LHB) when performing 
a biceps tenotomy and tenodesis. Specifically, we will investigate whether anatomic 
tensioning will improve functional outcome scores and decrease postoperative 
complications. We hypothesize that through a standardized method of anatomically 
tensioning the LHB tendon during tenodesis, patient outcomes will improve. 
 
Another purpose of this study is to provide further information referencing the 
longitudinal anatomy of the LHB, specifically at the myotendinous junction transition 
zone. There are multiple measurements that are unique to each individual. The 
measurements that we will analyze are the length from the supraglenoid tubercle to 
both the proximal and distal extents of the myotendinous junction. From these two 
measurements, we can calculate the total length of the myotendinous junction from 
beginning of muscle fibers to the end of tendinous fibers. We will also measure the 
width and circumference of the myotendinous junction. 
 
To date, these particular measurements have never been done before in an in vivo 
fashion. Our hope is that this analysis of the LHB myotendinous junction will identify 
any relationships with pathology at the LHB tendon. 

 
III. 
Administrative Organization 
a. The following sites will be utilized for this study: Loyola Center for Health at 
Burr Ridge, Loyola Center for Health at Oakbrook Terrace,  Loyola Outpatient 
Center in Maywood 
i. These locations will be where Dr. Salazar and Garbis will have their initial 
clinical encounter with these patients. During these encounters, they will 
be approached about the research project if they are eligible based on 
inclusion/exclusion criteria. 
b. The surgical encounters will occur at Loyola Ambulatory Surgery Center in 
Maywood, Russo Operating Center at Loyola Main campus, and Gottlieb 
Memorial Hospital 
 
IV. 
Study Design 
a. Experimental Design: Patients that meet the inclusion/exclusion criteria will be 
eligible for participation in the study. The design will be a single blinded format 
where the surgeon will be aware of what treatment the patient will receive 
(Control vs. Intervention). The patient will not be informed of what arm of 
treatment they were selected for. Block randomization will be utilized to place an 
equal number of patients into both groups.  
b. Study Population: Patients undergoing arthroscopic shoulder surgery with long 
head of the biceps tendon pathology. 
c. Sample size determination and power analyses:  
Based on previous studies, it is assumed that the pre-ASES score for all patients 
undergoing biceps tenodesis is approximately 45.  At 1 year post surgery, the 
standard of care group will increase to 85 (Mean difference = 40, STD=18).  It is 
hypothesized that the treatment group with anatomical fixation will increase to 
approximately 93 (Mean difference = 48, STD=18).  
 
The necessary sample size was calculated using 80% power of rejecting the null 
hypothesis (that there is no difference in change in ASES scores between the two 
groups of interest), when the population mean difference in ASES is ∆1 - ∆2 = 48 
- 40 = 8, with a standard deviation of 18, and with a significance level (alpha) of 
0.05.  This power and sample size calculation was computed using a two-sided 
two-sample equal-variance t-test. 
 
To achieve this power, at least 81 patients will need to be enrolled in each group.  
Patients will only be randomized once to this study.  If a patient has a repeat 
surgery, that case will not be eligible for randomization.  
 
d. Study outcomes/endpoints 
i. Study endpoint will be decided based on the power analysis that was 
calculated by the research team biostatistician. 
ii. Data collected: 
1. Demographics: Name, MRN, age, sex, hand dominance, ethnicity, 
profession, BMI 

2. Clinical Factors: Indication for surgery, procedures performed, 
past medical history of upper extremity pathology 
3. Medical History: Myocardial infarction, congestive heart failure, 
peripheral vascular disease, transient ischemic attack or 
cerebrovascular accident, dementia, chronic obstructive pulmonary 
disease, connective tissue disease, peptic ulcer disease, liver 
disease, diabetes, hemiplegia, chronic kidney disease, solid tumor, 
leukemia, lymphoma 
4. Measurements: (in mm) 
a. Supraglenoid tubercle to end of myotendinous junction 
(most distal tendinous fibers) 
b. Supraglenoid tubercle to start of myotendinous junction 
(most proximal muscle fiber) 
c. The width of the long head of the biceps tendon at the mid 
portion of the myotendinous junction  
 
V. 
Study Procedures 
a. Subject selection procedures 
i. Sampling plan 
1. Inclusion criteria: 
a. Patients at least 18 years of age undergoing arthroscopic 
shoulder surgery  
b. Operations that occur at Loyola University Medical Center 
(Maywood, IL), Loyola Ambulatory Surgery Center 
(Maywood, IL), or Gottlieb Memorial Hospital 
2. Exclusion criteria: 
a. Previous shoulder surgery involving the long head of the 
biceps tendon 
b. Younger than 18 years old 
c. Current pregnancy 
i. As per standard protocol with all surgeries, a urine 
pregnancy test is performed prior to surgery. If 
positive, the surgery will be cancelled and the 
patient will be excluded from the research study. 
ii. Recruitment procedures 
1. Where will recruitment occur? 
a. During the patient’s initial clinical visit, qualifying patients 
will be identified by Dr. Garbis or Dr. Salazar and will be 
approached for voluntary study participation. At that time, 
they will be given a written document for informed 
consent. The clinician will go over the consent and the 
patient will have the opportunity to ask any questions. If 
they agree to be in the study, then informed consent will be 

obtained then. If they wish to read over the consent further 
and make a decision later, then they will be approached on 
the day of surgery by a member of the research team. If 
they decide against the research study, then they will 
continue to receive the standard of care as per usual. 
b. If the patient wished to read the informed consent further at 
the clinical visit prior to making a decision, then they will 
be approached on the day of surgery by a member of the 
research. Once again, the entirety of the research project 
will be explained to the patient. If they wish to proceed, 
then written consent will be obtained. If they decide NOT 
to participate in the study, then they will continue on to 
surgery and receive the standard of care. 
 
2. Who will obtain consent? 
a. If obtained at the initial clinical visit, then it will be 
obtained by Dr. Garbis or Dr. Salazar. 
b. If obtained on day of surgery, then a member of the 
research team will obtain the written consent. 
3. What recruitment materials will be provided to the potential 
participant (brochures/information sheets/video presentation)? 
a. At the patient’s initial clinical visit, they will be given a 
copy of the informed consent that details specifics of the 
research study that we are conducting. It will be translated 
into a health comprehension level deemed appropriate by 
the IRB committee (7th grade). 
iii. Screening procedures  
1. What procedures are required for screening? 
a. At the initial outpatient office visit, qualifying patients will 
be further screened using the aforementioned 
inclusion/exclusion criteria. At that time, Dr. Garbis or Dr. 
Salazar will speak with the patient about the research study 
to its entirety, which will include the potential benefits, 
risks and alternatives. 
2. What is the screening schedule (number of visits, length of visits)? 
a. Patient will be screened during their initial outpatient office 
visit.  
b. Those patients that express interest will again be 
approached on the day of surgery. On this day, a member 
of the research team will explain to the patient, for the 
second time, the research project. 
3. Which screening tests/procedures are part of standard care and 
which are for research purposes only? 

a. A member of the research team will be at the office visit to 
obtain an ASES score prior to surgery and will contact 
patients via phone at 2 weeks, 6 weeks, 3 months, and 6 
months and one year after surgery.  
b. Standard of Care: Aspects of the physical examination 
including range of motion, strength, neurovascular status, 
and shoulder/elbow specific testing will be recorded by the 
surgeon in the chart per standard history and physical 
documentation.  
i. A member of the research team will gather this 
information via chart review. 
c. Research Specific: On the day of surgery, a member of the 
research team will ask the patient a short series of questions 
in order to calculate an American Shoulder & Elbow 
Surgeon (ASES) score as their preoperative score. The 
member of the research team administering the 
questionnaire will not be blinded. A specific description of 
the ASES questionnaire is detailed later in the protocol. 
This questionnaire will again be tested at the patient’s 6 
month follow up. 
4. What happens with screen failures (including any data gathered 
during screening)? 
a. Those patients that are not eligible based on the 
inclusion/exclusion criteria, will not be included in the 
study. 
b. The risk of patients incorrectly being included in the study 
despite screening the inclusion/exclusion criteria is 
essentially zero. 
i. All female patients are screened day of surgery with 
a pregnancy test. 
ii. Age of patient is obtained & confirmed at all 
clinical encounters. 
iii. History of prior surgery is obtained and verified at 
initial clinical visit.  
b. Randomization procedures  
i. Surgeon block randomization scheme will be used. This will be 1-1 
stratified for Dr. Salazar and Dr. Garbis.  
ii. Each surgeon will receive a stratified block randomization list provided by 
the department of Biostatistics and will be used for patients in 
chronological order for the surgical start time. Both surgeon schedules are 
accommodating of this because they are in the operating room on different 
days of the week. 
iii. Prior to the start of the surgery, the surgeon will be notified by a member 
of the research team if the patient will be part of the control group or the 
anatomic fixation group. 

c. Study Intervention 
i. Control Group: The control group patient will undergo biceps tenotomy 
and tenodesis based on surgeon feel on appropriate tensioning of the 
tendon (Current practice). 
1. Of note, there is no universal method or gold standard on how the 
long head of the biceps should be tensioned during bicep tenodesis. 
ii. Intervention Group: Patients that are randomized to the intervention group 
will undergo biceps tenodesis in a standardized, step-by-step protocol as 
outlined below 
d. Surgical Procedure Overview 
i. The initial indication for tenodesis is at the surgeon’s discretion, but after 
that decision is made, then the Control vs. intervention is determined 
based on our randomization scheme. 
ii. Per current surgeon protocol, all patients will receive a single injected pre-
operative nerve block and standard post-operative pain regimen.  
iii. As with every shoulder arthroscopy, a diagnostic scope of the shoulder 
will be performed, which will include evaluation of the intra-articular 
portion of the long head of the biceps tendon. If there is any instability or 
tendinopathy, then the surgeon will decide if biceps tenotomy and 
tenodesis is indicated. 
iv. Surgical Steps: Biceps Tenotomy & Tenodesis 
*Bolded steps are deviation from current, standard surgeon protocol 
1. Positioning of the patient will be in the standard beach chair 
position 
2. During the diagnostic arthroscopic shoulder scope, the long head 
of the biceps is inspected for any instability or tendinopathy, which 
would be an indication to perform tenotomy at the junction of the 
supraglenoid tubercle with arthroscopic scissors 
a. If Control group: Bicep tenotomy will occur now 
3. The patient will undergo all other indicated arthroscopic portions 
of the case (i.e. rotator cuff repair, subacromial decompression, 
rotator interval release, etc.) 
4. At the conclusion of the arthroscopic portion of the case, the 
patient’s arm will be placed with the elbow at 90 degrees of flexion 
and neutral forearm rotation. The trochar in the anterior shoulder 
portal and the arthroscope in the posterior shoulder portal will be 
left in the glenohumeral joint momentarily. The arthroscopic 
light will be shut off temporarily. Both will be secured to the 
shoulder using sterile ioban to maintain a good water seal & 
ensure that both are kept in the correct position for tenotomy 
later 
5. The standard mini-open subpectoral approach will be made along 
the anterior axillary fold 
6. Full thickness skin flaps are developed down to muscular fascia 

7. The biceps fascia is opened and the pectoralis major tendon is 
retracted superiorly 
8. The myotendinous junction of the long head of the biceps tendon 
and its location within the intertubercular groove will be marked 
using electrocautery 
9. The surgeon will then turn back to the glenohumeral joint, 
remove the ioban, turn the arthroscope back on, then perform 
the biceps tenotomy. All instrumentation will be removed from 
the glenohumeral joint at this time 
10. The surgeon will then turn to the mini-open subpectoral incision 
that was previously made and the long head of the biceps tendon 
will be retrieved 
11. A ruler will be used to measure the entire length of the long 
head of biceps tendon from origin to end of tendon fibers, 
origin to beginning of tendon fibers, and width of the tendon 
12. The arthroscopy camera will be used to take pictures of the 
biceps tendon at the myotendinous junction next to a ruler for 
scale 
a. Per standard protocol, these arthroscopic pictures will be 
inserted into the electronic medical record. This data will 
be retrospectively collected by a member of the research 
team. 
13. The tendon is tagged with a running, locking number 2 fiberwire 
suture at the mid substance of the myotendinous junction using the 
previously made electrocautery marks to set the tension  
14. The tendon is shortened 
15. The sutures from the biceps are passed through the Arthrex cortical 
button 
16. The pectoralis major tendon is retracted and 2 centimeters 
proximal to the distal insertion a unicortical bone tunnel is drilled 
in the bicipital groove with a 3.2 millimeter drill 
17. The wound is irrigated and the biceps button is threaded into this 
tunnel and then flipped. The suture is tensioned, securing the 
biceps against the groove 
18. The skin is closed in the usual fashion 
e. Study Assessments and Activities 
i. If indicated, patients will undergo biceps tenodesis, as described above 
1. Standard protocol for Dr. Salazar and Dr. Garbis is for patients to 
follow up at 2 weeks, 6 weeks, 3 months, and 6 months after 
surgery. 
a. A member of the research team will be at the office visit to 
obtain an ASES score prior to surgery and will contact 
patients via phone at 2 weeks, 6 weeks, 3 months, and 6 
months and one year after surgery.  

b. A member of the research team will retrospectively collect 
history and physical examination data using Dr. Salazar or 
Dr. Garbis’ notes (Complications, Range of motion, 
strength, special shoulder or elbow physical exam tests). 
2. Once the patient has completed their 6 month follow up 
appointment, all identifiable data from that patient will be deleted 
from all research records. 
ii. Description of American Shoulder and Elbow Surgeons Score (ASES) 
The ASES form was created by the Society of the American Shoulder and 
Elbow Surgeons to help standardize outcome measures by both combining 
a physician-rated and patient rated section. The total maximum score (and 
best outcome) is 100. Half of the score is weighted for pain and the other 
half for function. The final pain score is calculated by subtracting the 
visual analog scale from 10 and multiplying by 5. For the functional 
portion, each of the 10 separate questions are on a scale from 0 to 3. The 
functional portion total is then multiplied by 5/3 to make it a total of 50 
points. In summary, 50 points come from the visual analog scale and the 
other 50 come from the functional portion, which equals a possible total of 
100. 
 
1. What is your usual work/occupation? 
2. Usual sport/leisure activity? 
3. Do you have pain at night? Y/N 
4. Do you take pain killers such as paracetamol (acetaminophen), diclofenac, 
or ibuprofen? Y/N 
5. Do you take strong pain killers such as codeine, tramadol, or morphine? 
Y/N 
6. How many pills do you take on an average day? Quantity 
7. Intensity of pain? 0 to 10 (10 being the worst) 
8. Is it difficult to put on a coat? Unable to do, very difficult to do, somewhat 
difficult, not difficult 
9. Is it difficult for you to sleep on the affected side?  Unable to do, very 
difficult to do, somewhat difficult, not difficult 
10. Is it difficult for you to wash your back/do up bra?  Unable to do, very 
difficult to do, somewhat difficult, not difficult 
11. Is it difficult for you to manage toileting?  Unable to do, very difficult to 
do, somewhat difficult, not difficult 
12. Is it difficult for you to comb your hair?  Unable to do, very difficult to do, 
somewhat difficult, not difficult 
13. Is it difficult for you to reach a high shelf?  Unable to do, very difficult to 
do, somewhat difficult, not difficult 

14. Is it difficult for you to lift 10 pounds above your shoulder? Unable to do, 
very difficult to do, somewhat difficult, not difficult 
15. Is it difficult for you to throw a ball overhand?  Unable to do, very 
difficult to do, somewhat difficult, not difficult 
16. Is it difficult for you to do your usual work?  Unable to do, very difficult 
to do, somewhat difficult, not difficult 
17. Is it difficult for you to do your usual sport/leisure activity?  Unable to do, 
very difficult to do, somewhat difficult, not difficult 
 
iii. Provide a schedule of all study assessments and subject activities, 
including a tabular representation or timeline as applicable - 
 

 
 
VI. 
Safety Monitoring Plan 
a. Definition of adverse events, serious adverse events 
i. All surgical interventions are accompanied by a risk of blood loss, 
infection, and damage to surrounding structures.  Patients will be advised 
that post-op pain and stiffness is expected and normal. If this surgery is 
not successful, there may be need for additional surgeries. If the patient 
undergoes rotator cuff repair in addition to biceps tenotomy and tenodesis, 
there are risks that the rotator cuff repairs may fail to heal or even retear. 
Symptomatic retears may require further operative intervention. Scar 
tissue accumulation may also require further operations. All of these risks 
are routine risks associated with arthroscopic biceps tenotomy and 

tenodesis with or without rotator cuff repair. The only known possible risk 
specific to this research study will be an additional 1-2 minutes under 
anesthesia for those selected for the intervention group. This risk is 
considered low with minimal risk to the patient. There is minimal risk of 
loss of patient confidentiality. All data will be recorded and stored in the 
password protected Loyola R: drive, then will be de-identified prior to 
data analysis. 
 
b. What procedures will be used to monitor subject safety?   
i. As with all patient interactions, safety will be prioritized by all participants 
involved in caring for the patient. Our research project does not incur any 
increased safety concerns. However, due to the nature of research, 
participants in our study will inherently receive more attention because of 
increased interactions with members of the research team. If any concerns, 
suggestions, or questions arise during our research project, they will 
immediately be brought to the attention of the principal investigators of 
the study. 
c. Who (list names) will identify, document, and report adverse events? 
i. Adverse event identification will be the responsibility of each member of 
the research team, specifically, Dr. Dane Salazar and Dr. Nickolas Garbis. 
These events will be reported promptly to the IRB office. 
d. What are the stopping rules with regard to efficacy and safety? 
i. All patients involved in the study will be allowed to withdraw at any time. 
Consent may be revoked at any time prior to completion of the study, 
which is expected to be a duration of one year. All members of the 
research team will be held responsible for notifying the sponsors of the 
study (Dr. Salazar & Dr. Garbis) if patient safety is compromised. 
VII. 
Plan for patient identifiers and information 
a. Plan to protect patient identifiers for improper use and disclosure 
i. All patient health information (PHI), demographics and sensitive data will 
be kept on the Loyola provided secure server in an assigned password 
protected folder located on the R: drive. All paper records, if any, will be 
kept in a locked cabinet in the offices of the principal investigator. 
b. Removal of patient identifiers and record retention 
i. Upon completion of the study, electronically stored patient identifiers will 
be deleted from the R: drive and any paper records will be disposed of 
using Loyola Medical Center approved shred bins for such purpose. 
c. Individuals with access to protected health information 
i. Only research team members listed on the protocol will be granted access. 
d. Summary of the use of the data 
i. Data will be collected in a prospective manner, statistically analyzed and 
formatted for presentation at regional or national surgical meetings and/or 
publication in peer reviewed surgical/medical journals. 
 

VIII. Statistical Analysis Plan 
The primary aim of assessing change in the ASES score from baseline to post-surgery 
between the control and intervention groups will be assessed using a student’s t-test, 
as indicated in the study design. 
 
In addition, longitudinal mixed effects models will be used to estimate changes in 
ASES scores, over all time-points using a random effect for surgeon.  Other relevant 
patient characteristics such as age, sex, and Charlson score will be included to explore 
the adjusted relationship of the intervention and outcomes over time.   
 
IX. 
Literature Cited 
1. David, Tal S., and Jeffrey C. Schildhorn. “Arthroscopic Suprapectoral Tenodesis 
of the Long Head Biceps: Reproducing an Anatomic Length-Tension 
Relationship.” Arthroscopy Techniques, vol. 1, no. 1, 2012, pp. e127–e132., 
doi:10.1016/j.eats.2012.05.004. 
2. Denard, Patrick J., et al. “Anatomy of the Biceps Tendon: Implications for 
Restoring Physiological Length-Tension Relation During Biceps Tenodesis With 
Interference Screw Fixation.” Arthroscopy: The Journal of Arthroscopic & 
Related Surgery, vol. 28, no. 10, 2012, pp. 1352–1358., 
doi:10.1016/j.arthro.2012.04.143. 
3. Hussain, Waqas M., et al. “The Longitudinal Anatomy of the Long Head of the 
Biceps Tendon and Implications on Tenodesis.” Knee Surgery, Sports 
Traumatology, Arthroscopy, vol. 23, no. 5, 2014, pp. 1518–1523., 
doi:10.1007/s00167-014-2909-5. 
4. Jarrett, Claudius D., et al. “Minimally Invasive Proximal Biceps Tenodesis: an 
Anatomical Study for Optimal Placement and Safe Surgical Technique.” Journal 
of Shoulder and Elbow Surgery, vol. 20, no. 3, 2011, pp. 477–480., 
doi:10.1016/j.jse.2010.08.002. 
5. Lafrance, Russell, et al. “Relevant Anatomic Landmarks and Measurements for 
Biceps Tenodesis.” The American Journal of Sports Medicine, vol. 41, no. 6, 
2013, pp. 1395–1399., doi:10.1177/0363546513482297. 
6. Tao, Matthew A., et al. “Biceps Tenodesis: Anatomic Tensioning.” Arthroscopy 
Techniques, vol. 6, no. 4, 2017, doi:10.1016/j.eats.2017.03.033 
7. Wolf, Robert S., et al. “Long Head Biceps Tenotomy versus Tenodesis: A 
Cadaveric Biomechanical Analysis.” Arthroscopy: The Journal of Arthroscopic & 
Related Surgery, vol. 21, no. 2, 2005, pp. 182–185., 
doi:10.1016/j.arthro.2004.10.014. 
 
 
 
 
 

Document ID #:  212671ar4.011724 
Version Date: 01/17/2024 
 
IRB NUMBER:   212671021920 
 
LOYOLA UNIVERSITY CHICAGO 
HEALTH SCIENCES CAMPUS 
MAYWOOD, ILLINOIS 
DEPARTMENT OF ORTHOPAEDIC SURGERY 
 
INFORMED CONSENT 
 
Participant’s Name: _________________________________________________________ 
 
Medical Record Number: _____________________________________________________ 
 
PROJECT TITLE:  Restoring the anatomic tension relationship in long head of the biceps 
tenodesis 
 
THE APPROVAL FOR THIS PROJECT EXPIRES ON 01/17/2025. 
 
Participant Information 
 
About this research study 
Scientists do research to answer important questions which might help change or improve the 
way we do things in the future.   You are being asked to participate in a research study.   
 
Taking part in this research study is voluntary 
You may choose to not take part in this study or may choose to leave the study at any time.  
Deciding not to participate, or deciding to leave the study later, will not result in any penalty or 
loss of benefits to which you are entitled and will not affect your relationship with the Loyola 
university health system. 
 
This consent form will give you information about the study to help you decide whether you 
want to participate.  Please read this form, and ask any questions you have, before agreeing to be 
in the study.  
 
Overview and Key Information 
 
This information gives you an overview of the research.  More information about these topics 
may be found in the pages that follow.   
 
1. Why am I being asked to take part in this research study? 
We are asking you to take part in this research study because you are having an arthroscopic 
shoulder surgery (using a scope with a camera to see the inside of your shoulder).   
 

2. Why is this research being done? 
 
There are two reasons for why this research is being done. The first reason is to better 
study the anatomy of a tendon that we will encounter during your surgery. The second 
reason is to help develop a better step-by-step process of performing a specific portion of 
your surgery. We want to develop a more thorough surgical routine to potentially help 
patients after surgery so that they have less pain and weakness. 
 
3. What will happen to me during the study? 
You will undergo shoulder surgery like normal. During your surgery, we will take pictures of 
your biceps tendon as part of our study. In addition, you will be randomly selected (50/50 
chance) to have your surgery done in a more detailed, step-by-step process.  Neither you nor 
your doctor will be able to choose your treatment.  You will not be told which treatment you 
had. 
 
4. How long will I participate? 
Your participation in this study will last one year following your surgical procedure. You 
will be asked to complete your normal clinical visits after surgery. These clinic visits are the 
standard for any patient that undergoes this procedure and are not unique to this research 
project.  The only additional time required in participating in this study is that you will 
receive a phone call and be asked a series of 17 questions These phone calls will occur prior 
to surgery, at your 2 weeks, 6 weeks, 3 months, and 6 months and one year  by a member of 
the research team, which should take less than two minutes of your time. 
 
5. Will I benefit from the study? 
We do not know if you will benefit from participating in this study. For more information, 
please see Benefit section below.   
 
6. What are the risks? 
If you are selected to be in the intervention group of this study, you will be under anesthesia 
for approximately 1-2 additional minutes to allow the surgeon to perform the procedure.   For 
additional risks please refer to the risks and discomfort section. 
 
7. Do I have other options besides taking part in this study? 
Participation in research is completely voluntary. If you choose to not participate,  you will 
receive your doctor's usual treatment for your problem.  
 
8. Will I be paid to participate? 
You will not receive any payment for taking part in this study. 
 
9. Will it cost me anything to participate? 
There is no cost to you for taking part in this study. 
 
End of Overview and Key Information 
 

Please review the rest of this document for details about these topics and additional things 
you should know before making a decision about whether to participate in this research.   
 
 
PURPOSE OF RESEARCH:  You are being asked to participate in this study because you are 
having arthroscopic shoulder surgery (a scope with a camera to look inside your shoulder joint) 
 
The purpose of this study is to investigate whether a more thorough, step-by-step process to 
perform a portion of your surgery will result in decreased complications after surgery. In 
addition, we are studying a specific portion of your biceps tendon that has not been studied 
before. 
 
The study is being conducted Dr. Dane Salazar and Dr. Nickolas Garbis.  
 
Approximately 164 people will participate in this research.   
 
DESCRIPTION AND EXPLANATION OF PROCEDURES:  If you agree to participate in 
this study, you will be asked to do the following things:  
 
All participants in the study will have pictures taken of their biceps tendon during the procedure 
using a shoulder scope. Those images will be securely stored in the electronic health record, then 
studied by a member of the research team. 
 
You will be assigned by lottery to be in either group 1 or group 2.   
 
Group 1: The control group. This is the group that will have no change to the surgical 
procedure. This surgery would be the same as someone who did not participate in the 
study. You would still have biceps tenotomy (cutting of the biceps tendon) and tenodesis 
(the tendon is fixed at a different location on the bone). When placing the tendon at a 
different location on the bone, the surgeon will go by feel of what is not too tight or not 
too loose when performing this procedure. 
OR 
Group 2: The intervention group. This group will have a standardized, step by step 
process to perform a portion of your surgery. The specific portion that will be affected is 
called biceps tenotomy and tenodesis. What this means is that the biceps will be cut 
(tenotomy), then we will place the tendon at a different location on the bone (tenodesis).  
When placing the tendon at a different location on the bone, the surgeon will use 
markings on the tendon and bone to make sure that the tendon is put back in its 
natural/anatomical location.  If chosen to be in this group, then your surgery will be 
lengthened by about 1-2 minutes. 
 
Neither you nor your doctor can choose the group you will be in.  You will not be told which 
group you were in.  Your doctor can tell you when the study is completed which may not be for 
some time. 
 

All patients undergoing surgery will be asked to return for follow up visits at 2 weeks, 6 weeks, 3 
months, 6 months and one year after surgery. These are regularly scheduled follow up visits, 
regardless of participation in this research study. Prior to your visit you will recive a telephone 
questionnaire and be asked a short questionnaire about pain, quality of life,. This will take 
approximately 2 minutes of your time for each visit. 
 
If during your participation in the research project new information becomes available which 
would affect your being in the research project (such as better treatments or the side effects of 
the treatments), your doctor will discuss this new information with you and will help you make a 
decision about your continuing in the research. 
 
RISKS/DISCOMFORTS:  The surgical procedure you are assigned to receive may not be as 
effective or may be associated with more problems than the other surgical procedure in this study 
that you did not receive. 
 
While participating in this study, you may experience the following risks, side effect and/or 
discomforts:   
 
As per all surgical interventions, there is a risk of blood loss, infection, and damage to 
surrounding structures. Post-op pain and stiffness is expected and normal. If this surgery is not 
successful, there may be need for additional surgeries. If you undergo a rotator cuff repair in 
addition to biceps tenotomy and tenodesis, there are risks that the rotator cuff repairs may fail to 
heal or even re-tear. Symptomatic re-tears may require further operative intervention. Scar tissue 
accumulation may also require further operations. All of these risks are routine risks associated 
with arthroscopic biceps tenotomy and tenodesis with or without rotator cuff repair.  
 
There may be other side effects that we cannot predict or are currently unknown. 
 
BENEFITS:  We do not know if you will benefit from participating in this study.  The 
information we learn may help others. 
 
ALTERNATIVE TREATMENTS:  You do not have to participate in this research project to 
receive care and treatment at Loyola University Medical Center.  
 
Your doctor has discussed other options with you along with their risks and benefits. 
 
FINANCIAL INFORMATION:  Taking part in this study may or may not cost your insurance 
company more than the cost of getting treatment without being in this study.  Some health plan 
insurers will not pay the costs for people taking part in studies. Check with your health plan 
insurer to find out what they will pay for. Depending on your health insurance coverage, there 
may be out-of-pocket costs for you like co-payment of the standard visits, co-insurance, or 
deductibles. You will be responsible for these expenses.   
 
RESEARCH RELATED INJURY: 
In the event that you are injured or have side effects as a result of participating in this research 
project, your doctor will take the necessary steps to treat the problem.  There are no funds 

available from Loyola University Medical Center, Gottlieb Memorial Hospital, Loyola 
University Health System or Loyola University of Chicago to pay for the cost of care of the 
problem. You will be financially responsible for the cost of care of any problems.  By signing 
this form, you are not giving up any legal rights to seek to obtain compensation of injury. 
 
INFORMATION COLLECTED AND WHAT WILL HAPPEN TO IT:  In order to meet the 
goals of the research study (see Purpose of Research section of this consent), we will collect 
information on you, your test results, and how you do from you and your Loyola University 
Medical Center or Gottlieb Memorial Hospital medical records. The information will be 
collected by the study physician(s), the research nurses, data administrators and secretaries.   
 
Information about you will be provided to Loyola University of Chicago the research sponsor; 
data collection and study verification agencies; and/or government regulatory agencies such as 
the Food and Drug Administration.   
 
 
The information we will collect and send includes:  
 
__X__ DEMOGRAPHIC INFORMATION (e.g., name, address, phone number) 
__X__ MEDICAL RECORD (including, but not limited to, history and physical exam notes, 
progress notes, consultation reports, laboratory test results, AND/OR operative reports) 
__X__ PHOTOGRAPHS, VIDEOTAPES, OR DIGITAL OR OTHER RADIOGRAPHIC 
IMAGES (PHOTOGRAPHS OF YOUR BICEPS TENDON) 
We will collect and provide this information about you for as long as you are in the study. We 
anticipate that duration to be approximately one to two years  
 
Once the information is disclosed outside of Loyola University Medical Center or Gottlieb 
Memorial Hospital, it may no longer be protected by federal privacy laws. 
 
De-identified data from this study may be shared with others for research purposes.  We will 
remove or code any personal information that could identify you before data are shared with 
other researchers to ensure that no one will be able to identify you from the information we 
share, however this cannot be guaranteed. Once identifying information is removed, the 
information and samples cannot be withdrawn from further use.  You will not be asked to sign an 
additional consent for this use. 
 
It is possible that the research team, research nurses, data collection and/or study verification 
agencies, data administrators or staff, or the Food and Drug Administration will come to Loyola 
University Medical Center or Gottlieb Memorial Hospital and view the medical record (see 
above for description of content) and the research records.  They may take notes or copy pages of 
the medical record.  This is done to verify the accuracy of the information Loyola University of 
Chicago is sending to them. 
 

The results of this research study may be published in a journal for the purpose of advancing 
medical knowledge.  You will not be identified by name or by any other identifying information 
in any publication or report about this research. 
 
Consent for LUMC to use and disclose your medical information is required in order for you to 
participate in the study.   
 
This authorization does not expire. 
 
WITHDRAWAL OF CONSENT: Your consent to use and disclose your medical information 
for the purpose of this research study is completely voluntary.  You can withdraw your consent 
to use and disclose your information and your consent to participate in this study at any time 
without affecting your ability to receive care and treatment at Loyola University Medical Center 
or Gottlieb Memorial Hospital, as applicable, unrelated to the research study.  Withdrawal means 
that all study procedures and follow-up will stop and we will not send any more information 
about you to the sponsor of this research or its designees.  However, information already used 
and disclosed to the research sponsor prior to the time of your withdrawal from this study may 
continue to be used and disclosed by Loyola University of Chicago and the sponsor. 
 
As per normal protocol, we will have you follow up with Dr. Salazar or Garbis at regularly 
scheduled visits that are at 2 weeks, 6 weeks, and 6 months after your surgery. 
 
If you withdraw from the study, we will ask that you sign the form attached to this consent and 
send it to Amanda Spevacek (Research Coordinator) or give it to the study staff. Your 
withdrawal from the study will not have any effect on any actions by Loyola University Medical 
Center, Gottlieb Memorial Hospital, or Loyola University of Chicago taken before the attached 
form is received by Loyola University of Chicago. 
 
Your study doctor, the Institutional Review Board, the regulatory authorities, or the sponsors, Dr. 
Salazar or Dr. Garbis, may terminate the study at any time with or without your consent. 
 
CONSENT 
 
I have fully explained to ____________________________ the nature and purpose of the above- 
described procedure and the risks that are involved in its performance.  I have answered and will 
answer all questions to the best of my ability.  I may be reached at Robert.Burnham@lumc.edu 
 
________________________________________________Date:____/_____/____ 
Signature 
 
Dr. Dane Salazar or Dr. Nickolas Garbis, the principal investigators for this study, or their 
associates will be available to answer any questions you may have.  Robert Burnham 
(Orthopaedic resident) can be reached at:  Robert.Burnham@lumc.edu 
 

If you ever feel that you have been injured by participating in this study or if you have any 
questions concerning your rights as a research participant, you may contact either Kenneth 
Micetich, MD, Chair of the Institutional Review Board for the Protection of Human Subjects-
Loyola University Chicago Health Sciences Campus, at 708-216-2633 or Cynthia Tom-Klebba, 
MA, CIP, Director of the Human Research Subjects Protection Program at 708-216-4608.   
 
Although you have the right to revoke this authorization, you accept that such revocation will not 
apply to any uses and disclosures of your information that are described in the Loyola University 
Health System Notice of Privacy Practices or otherwise allowable under any Federal or State 
laws.   
 
You will receive a signed copy of this informed consent document. 
 
You have been fully informed of the above-described research program with its possible benefits 
and risks.  Your signature below indicates that you are willing to participate in this research 
study and agree to the use and disclosure of information about you as described above.  You do 
not give up any of your legal rights by signing this consent document.   
 
________________________________________________Date:____/_____/____ 
Signature:   Participant 
  
 
 
 
 
 
 
 
PROJECT TITLE:  Restoring the anatomic tension relationship in long head of the biceps 
tenodesis 
 
 
REVOCATION OF AUTHORIZATION TO 
RELEASE PROTECTED HEALTH INFORMATION (PHI) 
 
 
I, _____________________________________, hereby revoke my consent to participate 
in the study titled, ”Restoring the anatomic tension relationship in long head of the biceps 
tenodesis”, at Loyola University Medical Center, Gottlieb Memorial Hospital, or Loyola 
University of Chicago, as applicable.  I also revoke my consent to release information I provided 
to Loyola University Medical Center, Gottlieb Memorial Hospital, or Loyola University of 
Chicago, as applicable, that allowed use and disclosure of my medical information as outlined on 
the consent form, which I signed on ____/_____/____ (INSERT DATE CONSENT WAS 

SIGNED ORIGINALLY).  I understand that this revocation does not apply to any action Loyola 
University Medical Center, Gottlieb Memorial Hospital, or Loyola University of Chicago, as 
applicable, have taken in reliance on the consent I signed earlier.   
 
 
________________________________________________Date:____/_____/____ 
Signature:  Participant 
 
 
 
 
Please return this form to: 
 
Amanda Spevacek, Research Coordinator 
Loyola University of Chicago 
2160 South First Avenue 
Maywood, Illinois 60153

1 
 
Protocol Version #: 6 
  Version Date: 8/13/2024