Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.

Parc de Salut Mar

Status: Active, not recruiting

Conditions: Massive Rotator Cuff Tears; Shoulder Disease

Treatments: Procedure: Reverse Prosthesis; Device: Reverse Prosthesis Device; Procedure: Arthroscopic Decompression Surgery; Drug: Pain-Relief Medication; Procedure: Conservative treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05780229

PI18/00152

Details and patient eligibility

About

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.

Full description

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%.

Enrollment: 200 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Massive Rotator Cuff Tears: Mixed Methodology

Description:

Phase 1: 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 in 5 Spanish hospitals. Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals.

Treatment:

Procedure: Conservative treatment

Drug: Pain-Relief Medication

Procedure: Arthroscopic Decompression Surgery

Device: Reverse Prosthesis Device

Procedure: Reverse Prosthesis