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SURGICAL VERSUS CONSERVATIVE MANAGEMENT
FOR PATIENTS WITH ROTATOR CUFF TEARS:
A RANDOMIZED CONTROLLED TRIAL

INTRODUCTION
Rotator cuff (RC) disease is among the most common musculoskeletal disorders 1. It is a disabling
condition with high prevalence rate, particularly in the working population 2, causing high direct
and indirect costs 3. Patients with RC pathology may complain of symptoms ranging from minimal
discomfort without functional deficits to severe pain, weakness, and marked disability 4.
5, 6
Rotator cuff repair (RCR) has become extensively used , as surgical techniques, instruments,
suture materials and anchor designs improved with time leading to better results. With the
population aging, there may be a dramatic increase in the frequency of surgical treatment for
degenerative rotator cuff tears (RCT) 7, 8. However, there is still not a definite consensus on the best
management of patient with rotator cuff teas. This expensive process may incur additional health-
care expense with little benefit over conservative treatment.
Surgical repair may result in post-operative stiffness, infection, and failure of the repaired tendon to
heal. The risk of postoperative stiffness ranges anywhere from 0% to 14% 9-11, while the retear rate
ranges between 7% and 31% after repair of small to intermediate tears, and up to 94% for massive
tears 12-16.
17-19
The described successful rate of conservative treatment varies widely, from 33% to 92% . On
the other hand, it may predispose patients to continued irreversible tissue degeneration over time,
with primarily repairable tears progressing to irreparable tears. In this case, RCT that could be
addressed surgically can become irreparable. Prognostic factors are clinical presentation, duration
of symptoms and tear size 20. Several authors recommend surgery for patients with sudden onset of
weakness after an injury while prefer conservative treatment for those with pain without dramatic or
progressive weakness [43]. Unfortunately, current evidence is not sufficient to reach clear
indications for surgical or conservative management of rotator cuff tears.
Few published Level-I randomized controlled trials have compared the effectiveness of surgical and
conservative treatment for RCT, but results have not been univocal21-23.
22
Kukkonen et al found no significantly or clinically important difference in outcome of patients
older than fifty-five years of age with symptomatic, nontraumatic, isolated supraspinatus tears
treated by physiotherapy, or acromioplasty and physiotherapy, or arthroscopic rotator cuff repair,
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acromioplasty, and physiotherapy at two years follow-up. Moosmayer et al reported better
outcomes for small and medium-sized full-thickness tears repaied by open approach or mini-open
approach, but differences were small and may not represent clinical importance. In patients with
21
larger tear sizes and multiple tendon involvement, Heerspink et al observed significant
differences in pain and disabilities in favor of surgical treatment by mini-open approach, but not in
terms of functional outcome. Unfortunately, it should be noticed that available studies differ in
some aspects, such as tears characteristics, surgical techniques, physiotherapy protocols, scoring
systems, timing of outcome, limiting the possibility to compare results accurately.
The American Academy Orthopaedic Surgeons (AAOS) guidelines24 concluded that rotator cuff
repair (RCR) is an option for patients with chronic, symptomatic full-thickness RCT, but the quality
of evidence is unconvincing. There is little compelling evidence also for conservative treatment.
Thus, the AAOS recommendations are inconclusive.
Despite the lack of supporting evidences, RCR is frequently performed. The Italian National
Hospital Discharge Records (SDO) 25 shows that in the last 14 years more than 390 thousand RCR
were performed, with huge costs for the National Health System. The demand for RCR is expected
to increase by 172,66% in the next 10 years. If the current predictions are accurate, the hospital
costs alone for RC procedures are expected to be over 1 billion euros by 2025. The rising cost of
healthcare threatens the financial stability of our current system. To address this concern, future
health care practices must improve patient care while containing the rising costs.

Aim
The aim of this study is to compare surgical and conservative treatment of degenerative RCT, in
term of functional outcomes, rotator cuff (RC) integrity, and muscle atrophy or fatty degeneration,
to evaluate treatment effectiveness and obtain high quality evidences for the management of those
patients. Moreover, a novel, shoulder-specific device will be used to measure each patient’s motion
during activities of daily living and to evaluate how range of motion contributes to outcomes.

HYPOTHESIS AND SIGNIFICANCE

Based on the current literature and clinical recommendations, our hypothesis is that surgical and
conservative treatments of degenerative RCT may provide comparable clinical performance. If the
current practice of performing RCR for degenerative RCT is revised, clinical outcomes may
improve, costs for the Health System may decrease, and value of healthcare can be greatly
improved.

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METHODS
A prospective randomized controlled trial will be conducted to compare outcomes of surgical and
conservative treatment of degenerative RCT.

Sample size and randomization

The sample size calculation performed on the basis of previous studies showed that to achieve 80%
power with an alpha value of 0.05, a total of 130 patients would be required to detect a difference of
10.4 26, 27 points on the Constant Score. To compensate for possible loss of patients at follow up, we
plant to enroll 150 patients.
Patients will be randomly assigned to surgical repair (Group 1) or conservative treatment (Group 2)
using a computer-generated allocation, stratified for age, gender, and affected shoulder (right or
left).

Inclusion and Exclusion criteria

Inclusion criteria will be: age 45-70 years; atraumatic, symptomatic, isolated full-thickness
supraspinatus tendon tear documented with MRI; full range of motion of the shoulder.
Exclusion criteria will be: previous surgical treatment of the shoulder; frozen shoulder; radiological
osteoarthritis of the glenohumeral joint; cognitive disorders; neurological disease or language
barriers; tear involving the whole supraspinatus tendon combined with tear of two to three tendons;
muscle fatty degeneration > of stage 2 according to Goutallier classification28; muscle atrophy
evaluated with Tangent sign, exceeding stage 229; acute-on-chronic tears (after a traumatic event in
a shoulder with preceding episodes of symptoms); unable to undergo MRI scan for any reason.

Surgical treatment
An experienced orthopaedic surgeon will perform surgical procedures in patients from Group 1. A
diagnostic arthroscopy will be followed by subacromial decompression and biceps tenotomy in all
patients. The RCR will be performed placing one row of double loaded suture anchors. The arm
will be supported with an abduction sling pillow for 6 weeks. A validated postoperative protocol
will be used (http://www.moonshoulder.com/impactstudy.html).

Conservative treatment

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Conservative treatment will consist of a validated protocol for conservative RC rehabilitation
(http://www.moonshoulder.com/booklets/060109PatientRehabBooklet.pdf) under the supervision of
an experienced shoulder physiotherapist.
No supplementary treatment, such as cortisone injections or pain medication, will be given.

Outcomes evaluation
Outcomes will be assessed in both study groups at randomization and at 6, 12, and 24 months by
two independent examiners.
The following scores will be used:
- Constant score, ASES Shoulder Score, VAS score for pain
- Patient Reported Outcome Measures (PROMS):
Generic:
• Short-Form 36 (SF-36)
Disease-specific:
• Oxford Shoulder Score (OSS), Shoulder pain and disability index (SPADI), Shoulder
Disability Questionnaire (SDQ), Shoulder Rating Questionnaire (SRQ).
At each control visits, patients will be also asked to grade whether the shoulder is better or worse
compared with its preoperative state and if they are satisfied or dissatisfied with the treatment
outcome.

To investigate effectiveness of surgical and conservative treatment for RCT, all patients will
undergo magnetic resonance imaging (MRI) of the shoulder at randomization and at 6, 12, and 24
months post-operatively. MRI will be used to assess: RC integrity, extent of fatty degeneration
according to Goutallier classification modified by Fuchs28, amount of muscle atrophy by Tangent
sign29. Two independent examiners will assess MRI.

Patients’ shoulder motions will be monitored using a highly customizable inertial sensor. This
wearable device records raw acceleration data at high frequency. The software component allows
analyzing the gathered data, providing a comprehensive report of physical activity including
extremity motion, sitting, standing, postural transitions, walking, running, sleep, and falls. Patients
from both groups will wear the shoulder motion-monitoring device on their symptomatic wrists.
The surgical group will start on the first post-operative day, and the conservative group will begin
on their first day of physiotherapy. Data will be collected continuously 24 hours a day, 7 days a

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week, for 3 months. The average and peak values for elevation, internal rotation, external rotation
and abduction of the shoulder will be analyzed from the collected data and will be reported.

Statistical analysis
Blind statistics will be performed. To study the effects of the two treatment options, intention-to-
treat and per-protocol analysis will be performed.

EXPECTED OUTCOMES
RCT are a significant cause of morbidity and increased health-care expenses worldwide. Both
surgical and conservative treatments have shown good clinical outcomes, but the level of evidence
is poor. As a prospective randomized control trial, this study will provide the highest possible level
of evidence regarding the choice of treatments for degenerative RCT. It will provide highly relevant
clinical results using patient-reported outcomes, physical performance metrics, image-based
analysis of RC healing and tissue health. The results can be directly translated into clinical practice,
because they will support one treatment or the other.

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STUDY SCHEME

Treatment Follow-up Follow-up Follow-up

Clinical Protocol Screening/Inclusion
Procedures Visit (Surgical or
Visit Visit Visit
Conservative)

V1
V0 V2 V3 V4
Visits:
(Day -15) (Day 0) (6 months) (12 months) (24 months)

Informed Consent x

Inclusion/Exclusion criteria x

Demographic data x

Complete Physical Exam x

Joint Clinical Evaluation x

Clinical Evaluation:

Constant score, ASES

Shoulder Score, VAS score
for pain x x x x

PROMS x x x x
Patient global assessments of
the disease x x x

Patient satisfation x x x

Magnetic Resonance
Imaging :

RC integrity x x x x

Extent of fatty degeneration

(Goutallier classification
modified by Fuchs) x x x x

Muscle atrophy (Tangent

sign) x x x x

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FLOW CHART

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