Cost-effectiveness of rotator cuff repair surgery by open and arthroscopic techniques. randomized clinical trial

• Grant number: 19/02159-3
• Support Opportunities: Regular Research Grants
• Start date: June 01, 2019
• End date: May 31, 2022
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Mário Lenza
• Grantee: Mário Lenza
• Host Institution: Hospital Israelita Albert Einstein. Sociedade Beneficente Israelita Brasileira Albert Einstein (SBIBAE). São Paulo , SP, Brazil
• Associated researchers: Mario Ferretti Filho

Abstract

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. Purpose: to determine which method of repair of the rotator cuff, open or arthroscopic, has the best cost-effectiveness ratio. Methods: 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. Inclusion criteria: a) patients with complete or incomplete high-grade rotator cuff lesion whose previous treatment failed or who did not tolerate non-surgical treatment; b) patients in good clinical condition to undergo surgery; c) clear understanding of the Portuguese language and accepting to participate in the study by signing the informed consent form. Exclusion Criteria: patients with previous shoulder surgery; b) limited range of motion of the shoulder (joint stiffness); c) previous fractures in the affected shoulder; d) signs of glenohumeral osteoarthritis; e) neurological injury; f) patients who opt not to participate and / or are not willing to sign the informed consent form; g) patients unable to complete the follow-up evaluation (inability to read or complete the forms). The sample size was calculated with safety margin and is 50 patients per group. All randomized patients will be monitored preoperatively and at 6, 24 and 48 weeks postoperatively for clinical outcomes (Constant-Murley and EuroQol-5D-3L) along with pain assessment (VAS). The Pearson's chi-square test or Fisher exact tests will be used to analyze the results of the two groups in relation to the categorical variables and for the inferential analysis of the numerical clinical outcomes, mixed models will be used and, if the normal distribution is not adequate, generalized mixed models will be used. The significance level of 5% (alpha = 0.05) will be used for all statistical tests, such that tests have a value of less than 0.05 will be considered statistically significant. Cost-effectiveness analysis will also be performed, with Utilities calculations, quality adjusted life years (QALY), and incremental cost-effectiveness ratio (ICSI). (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

PIERAMI, RAFAEL; ANTONIOLI, ELIANE; OLIVEIRA, ISADORA; CASTRO, ISABELA QUEIROS; MANENTE, FELIPE; FAIRBANKS, PAULA; CARRERA, EDUARDO DA FROTA; MATSUMURA, BRUNO AKIO; LENZA, MARIO. Clinical outcomes and cost-utility of rotator cuff repair surgery by open and arthroscopic techniques: study protocol for a randomised clinical trial. BMJ OPEN, v. 10, n. 12, 2020. (19/02159-3)