Shoulder Pain Clinical Trial
Official title:
Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial
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.
The present study aims to determine which method of repair of the rotator cuff, open or
arthroscopic, has the best cost effectiveness ratio.
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.
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.
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.
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.
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.
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. Among the surgical options, the open method
is still considered the gold standard, with good or excellent results in over 90% of cases.
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 the
investigator's country. Several studies abroad 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 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 present study aims to compare the open and
arthroscopic methods for rotator cuff repair and determine which presents the best
cost-effectiveness ratio.
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 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.
Study Goal:
The present study aims to compare the open and arthroscopic methods for rotator cuff repair
and determine which presents the best cost-effectiveness ratio.
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