Clinical trial NCT05780229: Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.
Official title: Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Massive Rotator Cuff Tears
Shoulder Disease
Keywords: Mixed metholodgy
Massive Rotator Cuff Tears
Shoulder Disease
Comparative Effectiveness Research
Prosthesis
Arthroscopic Surgery
Conservative treatment
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Hospital Universitario Fundación Jiménez Díaz
name: Parc Taulí Hospital Universitari
name: Hospital Universitario La Paz
First posted: 2023-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with massive rotator cuff tears.

Brief summary: 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.

Detailed 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Relevant treatment outcome identified through the Phase 1 of the study.
timeFrame: Before treatment
measure: Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study).
timeFrame: At 6, 12, and 24 months after treatment
measure: Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments
timeFrame: Before and 6, 12, and 24 months after treatment
Secondary outcomes:
measure: Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
timeFrame: Before and 6, 12, and 24 months after treatment
measure: Ability to carry out normal daily activities measured with the Constant-Murley Score
timeFrame: Before and 6, 12, and 24 months after treatment
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Taulí Hospital Universitari
state: Barcelona
city: Barcelona
country: Spain
facility: Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.
name: Montse Ferrer Forés, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar, 08003 Barcelona, Spain,
name: Carlos Torrens Cánovas, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrufet C, Zamora V, Lizano-Barrantes C, Torrens C, Buron A, Calvo E, Peidro L, Miquel J, Barco R, Ferrer M. Relevant treatment outcomes for individuals aged 60 and older with massive rotator cuff tears: a qualitative study with 16 patients. Acta Orthop. 2025 Apr 14;96:322-330. doi: 10.2340/17453674.2025.43474.