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Cost-Effectiveness of Rotator Cuff Repair Methods

Primary Purpose

Rotator Cuff Injuries, Shoulder Pain, Shoulder Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rotator cuff repair surgery
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring Rotator Cuff, Rotator Cuff Tear, Rotator Cuff Tendinopathy, Shoulder Arthroscopy, Rotator Cuff Repair, Open Rotator Cuff Repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Alvorada MoemaRecruiting
  • Hospital Israelita Albert Einstein (HIAE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open rotator cuff repair

Arthroscopic rotator cuff repair

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 14, 2019
Last Updated
October 13, 2020
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Hospital Alvorada, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04146987
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Hospital Alvorada, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Outcome evaluators will be masked (blinded) and not involved with the study. The statisticians who will conduct the analyzes will also be masked to the treatment status until the analyzes are completed. Due to the types of interventions, it will not be possible to mask the participants and providers of the intervention.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open rotator cuff repair
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arthroscopic rotator cuff repair
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff repair surgery
Intervention Description
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair
Primary Outcome Measure Information:
Title
Constant-Murley Score (CM)
Description
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.
Time Frame
Measured continuously for 48 weeks after the intervention
Title
EuroQol-5D-3L (European Quality of Life)
Description
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).
Time Frame
Measured continuously for 48 weeks after the intervention
Secondary Outcome Measure Information:
Title
Simple Shoulder Test (SST)
Description
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.
Time Frame
Measured continuously for 48 weeks after the intervention
Title
Visual Analogue Pain Scale (VAS)
Description
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.
Time Frame
Measured continuously for 48 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Pierami, MD
Phone
+55 (11)982325308
Email
rafael.pierami@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Lenza, MD, Ph.D
Phone
+55 (11) 2151-1444
Email
mario.lenza@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Pierami, MD
Organizational Affiliation
SOCIEDADE BENEF ISRAELITABRAS HOSPITAL ALBERT EINSTEIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Alvorada Moema
City
São Paulo
State/Province
SP
ZIP/Postal Code
04541022
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Pierami, MD
Phone
+55 (11) 2186-9809
Email
rafael.pierami@einstein.br
Facility Name
Hospital Israelita Albert Einstein (HIAE)
City
São Paulo
State/Province
SP
ZIP/Postal Code
05652900
Country
Brazil
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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Cost-Effectiveness of Rotator Cuff Repair Methods

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