Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial
Phase: NA
Conditions: Rotator Cuff Injuries, Shoulder Pain, Shoulder Impingement, Shoulder Injuries, Shoulder Bursitis, Shoulder Tendinitis, Shoulder Lesions
Sponsor: Hospital Israelita Albert Einstein

Title: “Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and 
Arthroscopic Techniques. Randomized Clinical Trial” 
 
 
 
Responsable Researcher: Prof., M.D, Ph.D Mário Lenza 
Av. Albert Einstein, 627 – building A1 – 3º floor – Locomotive Program, 
Morumbi, São Paulo – ZIP code: 05652-900; Phone: (11) 2151.1444; e-
mail: mario.lenza@einstein.br 
 
 
Project Contributors:  
Rafael Pierami1,2 
Isadora Orlando de Oliveira¹ 
Mario Ferretti1 
1Hospital Israelita Albert Einstein, São Paulo, Brasil. 
2Hospital Alvorada,Moema, São Paulo, Brasil. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Project submitted to FAPESP for research grant request 
January 2019 

Abstract   
Background: Shoulder pain is one of the most common musculoskeletal 
complaints in orthopedic practice. Rotator cuff injuries account for up to 
70% of pain in the shoulder girdle. There is no clinical study carried out in 
Brazil comparing cost effectiveness between the open and arthroscopic 
methods of rotator cuff repair surgery. Purpose: to determine which 
method of repair of the rotator cuff, open or arthroscopic, has the best cost 
effectiveness ratio. Methods: a randomized clinical trial will be carried out 
in which patients with symptomatic rotator cuff lesion will be submitted to 
repair surgery by either open or arthroscopic technique and will be 
subsequently evaluated. Inclusion criteria: a) patients with complete or 
incomplete high-grade rotator cuff lesion whose previous treatment failed 
or who did not tolerate non-surgical treatment; b) patients in good clinical 
condition to undergo surgery; c) clear understanding of  the Portuguese 
language and accepting to participate in the study by signing the informed 
consent form. Exclusion Criteria: patients with previous shoulder surgery; 
b) limited range of motion of the shoulder (joint stiffness); c) previous 
fractures in the affected shoulder; d) signs of glenohumeral osteoarthritis; 
e) neurological injury; f) patients who opt not to participate and / or are not 
willing to sign the informed consent form; g) patients unable to complete 
the follow-up evaluation (inability to read or complete the forms). The 
sample size was calculated with safety margin and is 50 patients per group. 
All randomized patients will be monitored preoperatively and at 6, 24 and 
48 weeks postoperatively for clinical outcomes (Constant-Murley and 
EuroQol-5D-3L) along with pain assessment (VAS). The Pearson's chi-square 
test or Fisher exact tests will be used to analyze the results of the two 
groups in relation to the categorical variables and for the inferential analysis 
of the numerical clinical outcomes, mixed models will be used and, if the 
normal distribution is not adequate, generalized mixed models will be used. 
The significance level of 5% (alpha = 0.05) will be used for all statistical tests, 
such that tests have a value of less than 0.05 will be considered statistically 
significant. Cost effectiveness analysis will also be performed, with Utilities 
calculations, quality adjusted life years (QALY), and incremental cost 
effectiveness ratio (ICSI). 
 
 
Keywords: rotator cuff; surgery; arthroscopy; open repair; cost-
effectiveness; QALY 
 
 
 

Introduction 
 
 
          Musculoskeletal injuries are a major cost to the healthcare system. 
In 2004, 30% of the North American population had some kind of 
musculoskeletal disorder that required medical treatment; between 2002 
and 2004, the estimated cost of treating these changes was $ 510 billion. 
Shoulder diseases represent the third most common cause of these 
changes, behind only spinal and knee disorders. (referências) 
          An evaluation of the primary health care system in Cambridge, 
United Kingdom, showed that the average frequency of shoulder pain was 
9.5 per 1,000 individuals.  Of these, 86% had rotator cuff tendinopathy.  
North American data estimate that approximately 4.5 million patients 
annually seek medical attention due to shoulder pain; of these, two 
million have some symptoms related to the rotator cuff. About 250,000 
rotator cuff repair surgeries are performed annually in the United States 
of America (US), and with the continued increase in life expectancy and 
aging, there is a tendency to increase this number. (ref) 
          The rotator cuff is composed of the tendons of the subscapularis, 
supraspinatus, infraspinatus and teres minor muscles. The long portion of 
the biceps tendon also contributes to cuff function, which is to stabilize 
the humeral head in the glenoid cavity, preventing superior migration of 
the humeral head. (ref) 
          The possible lesions range from tendon degeneration (tendinosis / 
tendinopathy), through partial lesions (articular, interstitial or bursal), to 
complete lesions. Diagnosis is made by associating history and physical 
examination along with imaging methods, and magnetic resonance 
imaging (MRI) is considered the method of choice. (ref) 
          Currently the indication for surgical treatment is based on the 
persistence of symptoms and / or the degree of muscle weakness and / or 
size of the lesion, after a time of conservative treatment. In general, when 
opting for surgery, imaging can assist in the planning of surgical 
treatment, since it allows measuring the extent of the lesion (partial or 
total) and discriminating which tendons are involved (supraspinatus, 
infraspinatus, etc.). 
          Treatment of rotator cuff diseases depends on the type of injury, the 
patient's degree of activity, age, and the presence of symptoms. In 
general, tendon degeneration and partial lesions are treated non-
surgically, with physiotherapy, infiltrations and analgesic medications. 
Complete and incomplete lesions that did not respond well to 

conservative treatment, however, should be treated surgically. (ref) 
Among the surgical options, the open method is still considered the gold 
standard, with good or excellent results in over 90% of cases (ref). With 
the advent of arthroscopy and the evolution of arthroscopic instruments 
and implants in the last decade, the arthroscopic repair technique has 
gained space and is widely used in our country. Several studies abroad 
(REF) did not demonstrate superiority of one technique over another in 
terms of clinical outcomes. As the cost of arthroscopic surgery is higher, 
due to the equipment needed to perform it, it is important to establish 
which option has the best cost-effectiveness. 
          Some studies abroad (REF) even suggest the superiority of the open 
method over the arthroscopic method. However, there are no studies 
comparing cost-effectiveness between open and arthroscopic methods in 
Brazil. Therefore, the aim of the present study is to compare the open and 
arthroscopic methods for rotator cuff repair and determine which 
presents the best cost-effectiveness ratio. 
          This project will be submitted to FAPESP for research grant request 
in order to register it in TRIALS.GOV, as well for its publication and the 
acquisition of part of the surgical material (fixation anchors). 
 
 
 
 
Hypothesis 
 
          The hypothesis of this study is that the open method of rotator cuff 
repair will be more cost-effective compared to the arthroscopic method. 
 
 
Justification 
 
         In a systematic literature search, it was observed that there are no 
studies in the Brazilian literature comparing the cost-effectiveness of open 
and arthroscopic rotator cuff repair methods. Data from the international 
literature (REF) suggest that the open repair method is more cost-effective 
than the arthroscopic method (same clinical outcome and lower cost). 
          Thus, despite the high incidence of rotator cuff injury, there is 
insufficient evidence from the Brazilian experience to determine the best 
method for treating these injuries. So, this project proposes to conduct a 
study to answer the clinical question of which method, open or 

arthroscopic, has the best cost-effectiveness in the surgical treatment of 
rotator cuff injury. According to the levels of scientific evidence, the most 
appropriate study design to answer this clinical question is a randomized 
clinical trial (Figure 1). 
 
Study Goal 
 
    The aim of the present study is to compare the open and 
arthroscopic methods for rotator cuff repair and determine which 
presents the best cost-effectiveness ratio. 
 
Methodology 
 
Study Design 
 
          This project will be a multicenter randomized clinical trial and has a 
33 month schedule, where 1 month will be the period for organizing the 
structure in which patients will be seen, followed by 18 months of 
recruitment, 12 months for follow-up of outcomes, and 02 months for 
analysis of the results. The study will be conducted at Hospital Alvorada 
Moema (Shoulder and Elbow Surgery Center of Excellence), Sao Paulo, 
Brazil, in conjunction with the Israeli Institute of Teaching and Research at 
Albert Einstein Hospital, Sao Paulo, Brazil, and D Municipal Hospital Dr. 
Moysés Deutsch (M'Boi Mirim) between August / 2019 and December / 
2021. This project will be submitted to FAPESP for research grant request 
in order to register it in TRIALS.GOV, as well for its publication and the 
acquisition of part of the surgical material (fixation anchors). 
          This study will be submitted to the research ethics committee of 
Albert Einstein Hospital, Alvorada Moema Hospital and Dr. Moysés 
Deutsch Municipal Hospital (M'Boi Mirim). 
 
In order to ensure methodological quality in this project, we will 
follow the guidelines and flowchart (Figure 2) recommended by the 
Consolidated Standards of Reporting Trials (CONSORT Statement), which 
are: adequate randomization, sample calculation, description and 
justification for losses, use of the intention-to-treat principle and 
appropriate follow-up time (REF). 
 
 
 
 
 

Participants 
 
Patients participating in the study will be recruited and evaluated at 
the Shoulder and Elbow Surgery Center of Excellence at Alvorada Moema 
Hospital, a referral center for the treatment of shoulder and elbow 
injuries, and at Dr. Moysés Deutsch Municipal Hospital (M'Boi Mirim). 
Both hospitals will be co-participants in the project in question. Patients 
will undergo clinical evaluation, plain radiography and magnetic resonance 
imaging to confirm the diagnosis of rotator cuff injury. At this moment, 
the type of lesion will be evaluated, as well as its size, retraction (REF) and 
the degree of fatty infiltration of the muscular belly, according to the 
Goutallier classification (REF). The lesions will be classified as small 
(<1cm); moderate (1-3cm); large (3-5cm) or very large (> 5cm) (30). All 
patients will undergo examinations and preoperative clinical evaluation. 
 
Inclusion Criteria 
 
• Patients over 18 years old 
• Patients with complete rotator cuff injury, symptomatic, where there 
was failure or the patient could not support the non-surgical treatment; 
• Patients with high-grade partial rotator cuff injury where therapy failed 
or the patient did not support non-surgical treatment; 
• Patients without medical contraindications for surgery 
• Patients with good understanding of Portuguese language and who 
agree to participate and sign the Informed Consent Form. 
 
Exclusion Criteria 
 
 
• Patients under 18 years old  
• Patients with previous shoulder surgery,  
• Passive range of motion limitation (joint stiffness),  
• Previous fractures  
• Signs of glenohumeral osteoarthritis  
• neurological injury  
• Patients who choose not to participate and / or who do not accept to 
sign the consent form. 
 
 
 

Allocation and Randomization  
 
 
After eligibility assessment, all patients will be informed about the 
nature and purpose of the study and will only be included in the 
randomized distribution after signing the informed consent form. Patients 
will be consecutively allocated to one of two proposed treatment 
methods: open rotator cuff repair or arthroscopic rotator cuff repair. 
Allocation will be made according to instructions contained in opaque and 
sealed envelopes that will be numbered according to the computer 
generated randomization list (http://www.randomizer.org). The sealed, 
opaque envelope containing the method to be applied will be attached to 
the patient record. A person not associated with the study will open the 
envelope before the intervention and after the anesthetic technique is 
applied. 
 
 
Blinding of outcome evaluators 
 
 
Outcome evaluators will be masked (blinded) and not involved with 
the study. The statisticians who will conduct the analyzes will also be 
masked to the treatment status until the analyzes are completed. Due to 
the types of interventions, it will not be possible to mask the participants 
and providers of the intervention. 
 
Intervention 
 
 
Patients included in the study will undergo one of two possible 
interventions: open rotator cuff repair (1) or arthroscopic rotator cuff 
repair (2). 
 
Team 
 
 
 
Five surgeons with at least 03 years of surgical technique 
experience will participate of this study: Dr. Eduardo da Frota Carrera, 
group leader and specialist in shoulder and elbow surgery since 1983; Dr. 
Maria Thereza Calil Angelini, medical doctor graduated from 
UNICAMP/Sao Paulo (State University os Campinas) in 1999, with a 
residency in Orthopedics and Traumatology from UNIFESP (Federal 
University of Sao Paulo)  in 2003 and specialist in shoulder and elbow 
surgery from Santa Casa de São Paulo in 2005; Dr. Rafael Pierami, medical 

doctor graduated from UNIFESP (Federal University of Sao Paulo) in 2008, 
residency in Orthopedics and Traumatology from UNIFESP between 2009 
and 2012, specialist in shoulder and elbow surgery from UNIFESP in 2013; 
Dr. Bruno Akio Matsumura, medical doctor from USP (State University of 
Sao Paulo) between 2008 and 2013, residency in Orthopedics and 
Traumatology from USP between 2010 and 2013, specialized in shoulder 
and elbow surgery from USP in 2014; Dr. Vitor Rodrigues, medical doctor 
graduated from USP in 2011, residency in Orthopedics and Traumatology 
from USP between 2012 and 2015, specialist in shoulder and elbow 
surgery from USP in 2016. Also, may be part of the project and participate 
in surgeries the  residents of shoulder and elbow surgery from Hospital 
Alvorada Moema, as well as the residents of Orthopedics and 
Traumatology at this hospital. In addition, residents in shoulder and elbow 
surgery at Albert Einstein Hospital will participate in the study. 
 
As with patient randomization, surgeons will be randomized; it will 
be done by computer software (http://www.randomizer.org), where each 
surgeon will be assigned a number from 1 to 5. This will be attached to the 
patient's envelope and the responsible surgeon will be revealed prior to 
the intervention, immediately after application of anesthetic technique. 
 
Anesthetic Technique 
 
All patients will undergo balanced general anesthesia (inhalatory 
and intravenous) without brachial plexus block. At the end of the 
procedure, 20 milliliters of local anesthetic will be administered in the 
subacromial space. 
 
Open rotator cuff repair 
 
Patients will be positioned in a beach chair position with the 
affected limb pending off the table, allowing manipulation and full range 
of motion range. After asepsis, antisepsis and placement of sterile surgical 
fields, anterolateral incision will be made in the shoulder in question; the 
deltoid muscle belly will be gently divided along its fibers until exposure of 
the subdeltoid / subacromial bursa, which will be partially excised for 
exposure of the subacromial space and rotator cuff tendons. After 
mobilization and release of the ruptured tendons and debridement of the 
rotator cuff footprint, the tendon repair to the bone will be performed 
using 5.5m metal anchors, according to the preference and technique 

chosen by the surgeon. In all cases, the release of the coracoacromial 
ligament and acromioplasty will be performed. 
 
 
Arthroscopic Rotator Cuff Repair 
 
The patients will be positioned in lateral decubitus position, with 
the limb to be operated attached to a skin traction device, which trough a 
traction post and 07 kilograms (kg), will maintain the shoulder in the 
following position: abduction of 30 to 60 degrees and flexion of 20 to 30 
degrees. After asepsis, antisepsis and placement of impermeable sterile 
surgical fields, a posterolateral incision will be made in the shoulder for 
optic introduction, with a 50 mmHg pressure pump and a 0.90 flow, and 
inspection of the glenohumeral joint. If necessary, anterior accessory 
portal will be performed for intraarticular instrumentation. After joint 
inspection, the optic will be introduced into the subacromial space with 
detachment of the subacromial and subdeltoid bursa with the trocar. 
After visualizing the lesion, an accessory lateral portal will be performed. 
With the use of shaver blades, partial bursectomy will be performed and 
any adherence to the tendon stumps will be released, as well as 
debridement of the rotator cuff footprint. The tendon will then be 
reinserted to the bone using metallic 5.5mm anchors, according to the 
preference of each surgeon. The technique used, as well as the suture 
configuration and type of knot used will be defined by the surgeon, 
according to his preference. After tendon repair, the coracoacromomial 
ligament will be released, as well as acromioplasty. 
 
 
Postoperative rehabilitation 
 
All patients will undergo the same postoperative rehabilitation 
regimen: use of Velpeau sling for 6 weeks; pendulum exercises from the 
second week; active movement and recovery of the range of motion from 
the sixth week and strengthening from the twelfth week. 
 
Primary outcomes 
 
The Constant-Murley Score (CM) validated for the Portuguese 
language (33) will be measured preoperatively at 6, 24 and 48 weeks after 
the intervention. The evaluators will ask the patients to fill in the validated 

CM form for the Portuguese language and measure the range of motion 
with a goniometer. The CM scale covers different domains of shoulder 
function (pain, activities of daily living, range of motion and power), 
punctuating each of them; it ranges from 0 to 100, with higher scores 
indicating better function. 
 
EuroQol-5D-3L (European Quality of Life), a generic score developed 
to describe health-related quality of life (34) will also be assessed 
preoperatively, at 6, 24 and 48 weeks postoperatively. This score includes 
five health domains: mobility, self-care, usual activities, pain / discomfort 
and anxiety / depression; each domain has 3 levels: no problem; some 
problems and extreme problems. In addition, the EuroQol-5D-3L has a 
visual analog scale where the participant assigns a value between zero and 
one hundred to his or her own health condition (35). At the end of its 
application, EuroQol-5D-3L will provide a unique numerical value that can 
be used for longitudinal comparison between two time periods (pre and 
postoperative, for example). 
 
Secondary Outcomes 
 
Clinical outcome will also be assessed by the Simple Shoulder Test 
(SST), validated for Portuguese (36), preoperatively and at 6, 24 and 48 
weeks after the procedure. SST is a simple, quick and widely used 
questionnaire for shoulder function measurement; consists of 12 
dichotomous questions answered by the patient himself. Each positive 
answer (yes) is given a score; at the end of the questionnaire the 
percentage of positive answers (score) is made, and the higher the 
percentage, the better the shoulder function. Other outcomes measured 
will be VAS (visual analogue pain scale) at hospital discharge, 1, 2, 6, 24 
and 48 weeks after the intervention. This scale allows pain intensity to be 
measured with maximum interobserver reproducibility; it consists of a 10 
cm straight line with the ends determining the limits of pain sensation (no 
pain; worst pain ever experienced); the distance between zero (no pain) 
and the patient's demarcation defines the intensity of pain. Complications 
and failures of the proposed methods wills also be assessed. 
Failures will be characterized as need for additional surgical 
procedure and / or change of the initially proposed procedure. 
After the 48th week all patients will be submitted to Magnetic 
Nuclear Resonance (MRI)of the operated shoulder to evaluate the 
integrity and healing of the repair performed. 
 

Statistical Planning 
 
Descriptive analyzes of variables will be based on absolute 
frequencies and percentages for categorical variables and summary 
measures as means and standard deviations or medians and quartiles, as 
well as minimum and maximum values for numerical variables (37). 
Clinical scores will be represented by individual profile graphs separately 
by surgical technique group. 
The groups will be compared for the presence of categorical clinical 
outcomes (failures, complications and healing integrity) by Chi-square or 
Fisher's exact tests, depending on the distribution observed after data 
collection. 
For inferential analysis of numerical clinical outcomes, mixed 
models will be used and, if the normal distribution is not adequate, 
generalized mixed models will be used (38). The models will have time 
effects (preoperative, 6, 24 and 48 weeks after intervention), surgical 
technique group (open repair or arthroscopic repair) and the interaction 
effect between time and group. The size of the lesion (smaller than three 
cm or larger than three cm) will also be included in the models as a control 
variable, seeking to avoid possible biases. 
The analyzes will be performed with the aid of the SPSS program 
(39), considering a significance level of 5%. 
           
Sample Size Estimate 
 
The sample size estimate was obtained to detect differences 
between the open and arthroscopic repair groups in relation to the 
primary outcome of the study, Constant-Murley Score (CM) instrument 
after the intervention. 
Kukkonen's et. al study (40) estimated the clinically important 
minimal difference in CM score in 10.4 points in patients with rotator cuff 
rupture after three months of surgical treatment by the arthroscopic 
method. 
The estimated sample size of 45 patients per group, 90 patients in 
total, would reach 90% power to detect a 10.4 point difference between 
groups in the CM instrument postoperative score with standard deviation 
of up to 15 points with significance level of 5% using a t-Student test. 
Predicting a loss of around 10% at 12 months of follow-up, we aimed to 
recruit 50 patients in each group. 

The sample size estimate calculations were performed with the aid 
of the PASS software (41). 
 
Intention to Treat Principle 
 
Patients who for any reason demonstrate treatment failure or 
require additional interventions will be followed and their results included 
in the group in which they were initially randomized according to the 
intention-to-treat principle. 
 
Economic analysis 
 
Analytical Decision Model: Decision Tree 
Evaluated Strategy: To analyze the cost-effectiveness between open 
and arthroscopic repair techniques for patients with symptomatic rotator 
cuff injury. 
Intervention period: From preoperative questionnaires to patient 
follow-up 48 weeks after surgery. 
For the cost effectiveness model, a sensitivity analysis will be 
performed in order to highlight possible variations in the model and the 
impact of variations in the final decision of the best treatment strategy, by 
calculating Utilities (EQ-5D-3L together with EVA), quality-adjusted life 
years (QALY) and incremental cost-effectiveness ratio (ICER). 
 
The analysis will be conducted taking into account open versus 
arthroscopic treatment considering direct and indirect costs related to the 
surgical event and the patient's treatment time, with all costs generated 
during the intervention period. According to the recommendations of the 
Ministry of Health Methodological Guidelines, health outcomes and costs 
will not be discounted at a 5% discount rate. The costs analyzed will refer 
to the treatment in the study and may also simulate other scenarios 
according to the need for evidence of effectiveness in other health system 
scenarios. 
 
Conflict of Interest Statement 
 
The authors declare that there are no conflicts of interest in the 
project entitled “Cost-Effectiveness of Rotator Cuff Repair Surgery by 
Open and Arthroscopic Techniques. Randomized Clinical Trial”. 
 
 
 

Expected results 
 
Patients from both groups will have clinically better outcomes after 
the surgical procedure, but considering international experience, it is 
expected that the open rotator cuff repair method will be more cost-
effective when compared to the arthroscopic method. 
 
Schedule 
The research project follows the following steps described in the 
table below: 
Research Steps (Included -Time Analysis) 
Period to be realized (month / year) 
Research grant request from FAPESP 
01 to 03/2019 
Submission for ClinicalTrials registration: http://clinicaltrials.gov/ 
09/02/2019 to 09/30/2019 
Trials submission for protocol publication: 
http://www.trialsjournal.com/ 
08/12/2019 to 09/30/2019 
Organization of patient recruitment and treatment structure 
08/01/2019 to 08/31/2019 
Patient recruitment 
09/2019 to 09/2021 
Outcome analysis and follow-up (override recruitment) 
09/2019 to  09/2022 
Data Analysis - Description of Results 
10/01/2022 à 11/01/2022 
Submitted for publication: JOURNAL OF BONE AND JOINT SURGERY-
AMERICAN VOLUME 
12/01/2022 à 12/31/2022 
 
 
Dissemination and Evaluation 
This research project, within the IIEPAE (Israeli Institute of Research 
and Teaching Albert Einstein) postgraduation program, will cover 
participants from scientific initiation to master's and doctoral degrees; 
Orthopedics residents at Alvorada Moema Hospital and Albert Einstein 
Hospital will be able to participate in surgical procedures as part of the 
internship. The protocol will be submitted for publication in an 
international journal and the results will be published in presentations at 
national and international orthopedic congresses and will be submitted 
for publication in an indexed international journal. 
 
Details of the physical and technological infrastructure to be used 
To carry out this project will be used the physical and technological 
structure of the Locomotive Program of Hospital Israelita Albert Einstein, 
Hospital Alvorada Moema and Municipal Hospital Dr. Moysés Deutsch 
(M'Boi Mirim). Expenses foreseen in the initial budget of this project were 
calculated, for which we are requesting funding for FAPESP: 

ITEM 
Quantity 
Unit Value (R$) 
Total Value 
(R$) 
Metal Anchors 5.5mm 
140 
968,00 
135.520 
Protocol Publication Rate in TRIALS 
Journal 
01 
1.000 
1.000,00 
Total 
 
 
136.520,00 
 
 
Technical Justification for the use of anchors 
Rotator cuff repair surgeries were initially performed openly using 
transosseous points for tendon repair to the bone. With the evolution of 
this type of surgery, the anchors were developed to provide the same 
quality and strength of repair, without the need for extensive surgical 
exposure. Thus, they become indispensable for performing rotator cuff 
repair surgery, either by the open technique with mini incisions, or by the 
arthroscopic technique, as it provides the same strength and quality of 
repair as the transosseous point and allows the surgical procedure to be 
performed with smaller incisions and lower risk of injury associated with 
surgical exposure.