Cost-Utility of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques: Study Protocol for a Randomized Clinical Trial

Abstract

Background: Shoulder pain is one of the most common musculoskeletal conditions in orthopedic practice. Rotator cuff injuries account for up to 70% of pain in the shoulder girdle. However, there is still no consensus on the best surgical treatment of patients with degenerative rotator cuff injuries, considering cost-effectiveness and cost-utility analysis between the open and arthroscopic methods of rotator cuff repair. The objective of this trial is to compare the efficacy, cost-effectiveness and cost-utility of open and arthroscopic procedure for rotator cuff repair. Methods: The trial is a two-group, parallel design, randomized controlled study. A total of 100 patients with symptomatic rotator cuff lesion will be allocated to repair surgery and randomized by either open or arthroscopic technique in a 1:1 ratio, considering smoking (yes or no), lesion size (less than 3 cm or more than 3 cm) and diabetes (present or absent) as stratification factors. All patients will be included in the same rehabilitation program after the intervention. The primary outcome measure will be the Constant-Murley score at 48 weeks post-surgery. Secondary outcomes include cost-effectiveness, cost-utility, pain, complications and clinical analysis, using the EuroQol 5-D3L, the simple shoulder test (SST), Visual Analogue Pain Scale (VAS), integrity of the repair evaluated through magnetic resonance imaging, complications and failures of the proposed methods. Theses outcomes will also be measured continuously for 48 weeks after the intervention. For the cost-effectiveness analyses, we will use the VAS and the Constant-Murley Score as measures of effectiveness; for the cost-utility analyses, we will use the EuroQol- 5D-3L as a measure of utility in terms of incremental cost per quality-adjusted life-years (QALY). Discussion: There are two options of the rotator cuff repair surgery, open and arthroscopic and, both procedure present good clinical results. However, considering that the arthroscopic surgery present supposedly higher costs, is necessary to understand if these costs present a best cost-effectiveness and cost-utility for the patient.Trials registration: ClinicalTrials.gov register: NCT04146987. Registered October 31, 2019