Clinical trial NCT04146987: Cost-Effectiveness of Rotator Cuff Repair Methods
Official title: Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Injuries
Shoulder Pain
Shoulder Impingement
Shoulder Injuries
Shoulder Bursitis
Shoulder Tendinitis
Shoulder Lesions
Keywords: Rotator Cuff
Rotator Cuff Tear
Rotator Cuff Tendinopathy
Shoulder Arthroscopy
Rotator Cuff Repair
Open Rotator Cuff Repair
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Hospital Alvorada
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will undergo a 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 and the degree of fatty infiltration of the muscular belly, according to the Goutallier classification. The lesions will be classified as small (\<1cm); moderate (1-3cm); large (3-5cm) or very large (\> 5cm). All patients will undergo examinations and preoperative clinical evaluation.

Patients will be consecutively allocated to one of two proposed treatment methods: open rotator cuff repair or arthroscopic rotator cuff repair.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 a good understanding of the 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;
* Patients with limited range of motion of the shoulder (joint stiffness);
* Patients with previous fractures in the affected shoulder;
* Patients with signs of glenohumeral osteoarthritis;
* Patients with neurological injury;
* Patients who opt not to participate and/or are not willing to sign the informed consent form;
* Patients unable to complete the follow-up evaluation (inability to read or complete the forms).

Primary outcomes:
measure: Constant-Murley Score (CM)
timeFrame: Measured continuously for 48 weeks after the intervention
measure: EuroQol-5D-3L (European Quality of Life)
timeFrame: Measured continuously for 48 weeks after the intervention
Secondary outcomes:
measure: Simple Shoulder Test (SST)
timeFrame: Measured continuously for 48 weeks after the intervention
measure: Visual Analogue Pain Scale (VAS)
timeFrame: Measured continuously for 48 weeks after the intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Alvorada Moema
state: SP
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein (HIAE)
state: SP
Study officials:
affiliation: SOCIEDADE BENEF ISRAELITABRAS HOSPITAL ALBERT EINSTEIN
name: Rafael Pierami, MD
role: PRINCIPAL_INVESTIGATOR
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