The purpose of this study is: 1) to identify relevant treatment outcomes for people with massive rotator cuff tears of the shoulder joint, according to the experience of the affected people, to facilitate treatment shared decision-making during the specialist consultation in Spain; 2) to compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.

Primary Objectives:

Phase 1 (Qualitative):

1. To explore the perceptions, believes, experiences and coping strategies that are relevant results for people undergoing treatment of massive rotator cuff tears.
2. To identify the relevant outcomes for people with massive rotator cuff tears, and their experiences with the shared-decision making process.

Phase 2 (Quantitative):

a) To compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.

Outline:

Phase 1:

A qualitative, interpretative, descriptive study with a hermeneutics phenomenological approach was conducted from an 'etic' (from phonetic) perspective. Through hermeneutical phenomenology it was intended to describe and understand the multiple meanings that people with massive rotator cuff tears give to their experience and the results they expect from their treatment. A theoretical sampling of maximum variation was carried out using a segmentation criterion, being the evaluation before or after the treatment in those patients who attended the visit of the specialist in Spain.

Phase 2:

This is a prospective observational study of a cohort with rotator massive cuff tears treated either with conservative treatment, arthroscopic decompressive surgery, or reverse prosthesis.

Participants were consecutively recruited in 5 Spanish hospital departments (located in two autonomous communities). Patients eligible for inclusion were: age 65-85 years, without previous surgical treatment in the affected shoulder, and complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging. Patients were excluded if they have a neurological injury and/or an active infection.

Demographic and clinical characteristics at baseline are recorded at clinical sites and in the interview pretreatment, and include birthdate, sex, intervention, date of intervention, date of rehabilitation, chronic conditions, smoking status, employment status, and a question about the relevant outcome identified through the Phase 1.

Quality of Life questionnaires are administered centrally by telephone interviews before treatment and during follow-up at 6, 12 and 24 months after treatment. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Oxford Shoulder Score (OSS); and (2) the EuroQol-5 Dimension (EQ-5D-5L).

The sample size calculated to detect differences between groups (0.07 points in the EQ-5D-5L utility index, minimal important difference) was of 200 patients considering the three treatment groups, given a statistical power of at least 80% at a significance level of 5%, and lost to follow-up of 10%.

Inclusion Criteria:

• Age between 65 and 85 years.
• No previous surgical treatment in the affected shoulder.
• Complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging;

Exclusion Criteria:

• Neurological injury.
• Active infection.

Patients with massive rotator cuff tears.

Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation.

Data and associated documentation will be made available to users only under a data sharing agreement that provides for:

• A commitment to use the data only for research purposes and not to identify any individual participant;
• A commitment to protect data through the use of appropiate information technology;
• A commitment to destroy or return the data after analyses are complete.

The data and definitive documentation of the project will be stored centrally on virtual servers (up to 40 TB) and research storage infrastructures provided by the Hospital del Mar Medical Research Institute, during the lifetime of the project. Thereafter, the data will be kept for the recommended period of 20 years, as set out in the Medical Research Council's guideline "Personal Information in Medical Research" (section 7).

Data sharing agreement among institutions.