Cost-Effectiveness of Rotator Cuff Repair Methods

NCT04146987 | Unknown

• 1 other identifier: 032019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Simple Shoulder Test (SST)

  Measured continuously for 48 weeks after the intervention

• Visual Analogue Pain Scale (VAS)

  Measured continuously for 48 weeks after the intervention

Study Arms (2)

Open rotator cuff repair

ACTIVE COMPARATOR

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

Arthroscopic rotator cuff repair

ACTIVE COMPARATOR

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

Interventions

Rotator cuff repair surgery PROCEDURE

Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair

Arthroscopic rotator cuff repair; Open rotator cuff repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Hospital Alvorada: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Hospital Alvorada Moema

São Paulo, São Paulo, 04541022, Brazil

RECRUITING

Hospital Israelita Albert Einstein (HIAE)

São Paulo, São Paulo, 05652900, Brazil

ACTIVE NOT RECRUITING

Related Publications (43)

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MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafael Pierami, MD

  SOCIEDADE BENEF ISRAELITABRAS HOSPITAL ALBERT EINSTEIN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Pierami, MD

CONTACT

+55 (11)982325308; rafael.pierami@einstein.br

Mario Lenza, MD, Ph.D

CONTACT

+55 (11) 2151-1444; mario.lenza@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 31, 2019
• Study Start: August 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)