Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-01
Study Completion Date
2022-12-01
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Rotator Cuff Injuries
Shoulder Pain
Shoulder Impingement
Shoulder Injuries
Shoulder Bursitis
Shoulder Tendinitis
Shoulder Lesions
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Patients will be consecutively allocated to one of two proposed treatment methods: open rotator cuff repair or arthroscopic rotator cuff repair.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Rotator cuff repair surgery
Intervention Type
PROCEDURE
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair
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.
Group Type
ACTIVE_COMPARATOR
Rotator cuff repair surgery
Intervention Type
PROCEDURE
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair
Interventions
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Rotator cuff repair surgery
Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
* 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).
* 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Alvorada
OTHER
Sponsor Role
collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Sponsor Role
collaborator
Hospital Israelita Albert Einstein
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rafael Pierami, MD
Role: PRINCIPAL_INVESTIGATOR
SOCIEDADE BENEF ISRAELITABRAS HOSPITAL ALBERT EINSTEIN
Locations
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Hospital Alvorada Moema
São Paulo, São Paulo, Brazil
Site Status
RECRUITING
Hospital Israelita Albert Einstein (HIAE)
São Paulo, São Paulo, Brazil
Site Status
ACTIVE_NOT_RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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RESULT
Handoll HH, Hanchard NC, Lenza M, Buchbinder R. Rotator cuff tears and shoulder impingement: a tale of two diagnostic test accuracy reviews. Cochrane Database Syst Rev. 2013 Oct 7;2013(10):ED000068. doi: 10.1002/14651858.ED000068. No abstract available.
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RESULT
Hanchard NC, Lenza M, Handoll HH, Takwoingi Y. Physical tests for shoulder impingements and local lesions of bursa, tendon or labrum that may accompany impingement. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD007427. doi: 10.1002/14651858.CD007427.pub2.
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RESULT
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van der Zwaal P, Thomassen BJ, Nieuwenhuijse MJ, Lindenburg R, Swen JW, van Arkel ER. Clinical outcome in all-arthroscopic versus mini-open rotator cuff repair in small to medium-sized tears: a randomized controlled trial in 100 patients with 1-year follow-up. Arthroscopy. 2013 Feb;29(2):266-73. doi: 10.1016/j.arthro.2012.08.022. Epub 2012 Dec 1.
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RESULT
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Kose KC, Tezen E, Cebesoy O, Karadeniz E, Guner D, Adiyaman S, Demirtas M. Mini-open versus all-arthroscopic rotator cuff repair: comparison of the operative costs and the clinical outcomes. Adv Ther. 2008 Mar;25(3):249-59. doi: 10.1007/s12325-008-0031-0.
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Vitale MA, Vitale MG, Zivin JG, Braman JP, Bigliani LU, Flatow EL. Rotator cuff repair: an analysis of utility scores and cost-effectiveness. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):181-7. doi: 10.1016/j.jse.2006.06.013.
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Hui YJ, Teo AQ, Sharma S, Tan BH, Kumar VP. Immediate costs of mini-open versus arthroscopic rotator cuff repair in an Asian population. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684496. doi: 10.1177/2309499016684496.
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Pierami R, Antonioli E, Oliveira I, Castro IQ, Manente F, Fairbanks P, Carrera EDF, Matsumura BA, Lenza M. Clinical outcomes and cost-utility of rotator cuff repair surgery by open and arthroscopic techniques: study protocol for a randomised clinical trial. BMJ Open. 2020 Dec 28;10(12):e043126. doi: 10.1136/bmjopen-2020-043126.
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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032019
Identifier Type: -
Identifier Source: org_study_id
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Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
NCT06394856
COMPLETED
NA
The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing
NCT04421417
SUSPENDED
NA
Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes
NCT01912027
UNKNOWN
NA
Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation
NCT01815177
COMPLETED
NA
Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial
NCT03913611
RECRUITING
NA
Rotator Cuff Pathway
NCT03717753
COMPLETED
NA
Operative Versus Non-operative Management of Subacromial Impingement
NCT00637013
ACTIVE_NOT_RECRUITING
NA
Early Mobilization Following Mini-Open Rotator Cuff Repair
NCT01741272
COMPLETED
PHASE4
Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement
NCT05084781
UNKNOWN
NA
Suprascapular Nerve Block Efficacy for Shoulder Surgery
NCT04364542
UNKNOWN
NA
Operative or Conservative Treatment for Subacromial Impingement Syndrome?
NCT00428870
UNKNOWN
NA
Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel
NCT01404143
COMPLETED
NA
Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair
NCT03533088
COMPLETED
NA
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
NCT03021733
COMPLETED
Shoulder Functional Performance After Shoulder Surgery
NCT04388306
COMPLETED
Conservative or Operative Treatment for the Shoulder Impingement Syndrome?
NCT00349648
UNKNOWN
NA
Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain
NCT04175184
COMPLETED
NA
The Study of Different Treatment Programs for Patients With Frozen Shoulder
NCT01249040
UNKNOWN
NA
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
NCT02971072
COMPLETED
NA
Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008
NCT00828256
UNKNOWN
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
NCT00290888
COMPLETED
NA