Cost-Effectiveness of Rotator Cuff Repair Methods

October 13, 2020 updated by: Hospital Israelita Albert Einstein

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04541022
        • Recruiting
        • Hospital Alvorada Moema
        • Contact:
      • São Paulo, SP, Brazil, 05652900
        • Active, not recruiting
        • Hospital Israelita Albert Einstein (HIAE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: Rotator cuff repair surgery
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair
ACTIVE_COMPARATOR: Arthroscopic rotator cuff repair
The patients will be positioned in lateral decubitus position, with the arm to be operated attached to a skin traction device, which trough a traction post and 07 kg, will maintain the shoulder in the following position: abduction of 30 to 60 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 GU joint. After joint inspection, the optic will be introduced into the subacromial space with detachment of the subacromial and subdeltoid. Using shaver blades, partial bursectomy will be performed as well as debridement of the rotator cuff footprint. The tendon will then be reinserted to the bone using metallic 5.5mm anchors. After tendon repair, the coracoacromomial ligament will be released, as well as acromioplasty.
Procedure: Rotator cuff repair surgery
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley Score (CM)
Time Frame: Measured continuously for 48 weeks after the intervention
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
EuroQol-5D-3L (European Quality of Life)
Time Frame: Measured continuously for 48 weeks after the intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simple Shoulder Test (SST)
Time Frame: Measured continuously for 48 weeks after the intervention
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
Visual Analogue Pain Scale (VAS)
Time Frame: Measured continuously for 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.
Measured continuously for 48 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Hospital Alvorada

Investigators

  • Principal Investigator: Rafael Pierami, MD, Sociedade Benef Israelitabras Hospital Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (ACTUAL)

October 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 032019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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