Cost-Effectiveness of Rotator Cuff Repair Methods

Shoulder Pain Clinical Trial

Official title:

Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146987
• Other study ID #: 032019
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2020
• Source: Hospital Israelita Albert Einstein
• Contact: Rafael Pierami, MD
• Phone: +55 (11)982325308
• Email: rafael.pierami[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bursitis
• Rotator Cuff Injuries
• Shoulder Bursitis
• Shoulder Impingement
• Shoulder Impingement Syndrome
• Shoulder Injuries
• Shoulder Lesions
• Shoulder Pain
• Shoulder Tendinitis
• Tendinopathy
• Wounds and Injuries

Intervention

Procedure:
• Rotator cuff repair surgery
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair

Locations

Country	Name	City	State
Brazil	Hospital Alvorada Moema	São Paulo	SP
Brazil	Hospital Israelita Albert Einstein (HIAE)	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Fundação de Amparo à Pesquisa do Estado de São Paulo, Hospital Alvorada

Country where clinical trial is conducted

Brazil, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant-Murley Score (CM)	The Constant-Murley Score (CM) validated for the Portuguese language. 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.	Measured continuously for 48 weeks after the intervention
Primary	EuroQol-5D-3L (European Quality of Life)	EuroQol-5D-3L (European Quality of Life), a generic score developed to describe health-related quality of life 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. 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).	Measured continuously for 48 weeks after the intervention
Secondary	Simple Shoulder Test (SST)	SST is a simple, quick and widely used questionnaire for shoulder function measurement; it 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.	Measured continuously for 48 weeks after the intervention
Secondary	Visual Analogue Pain Scale (VAS)	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.	Measured continuously for 48 weeks after the intervention