Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.
- Conditions
- Massive Rotator Cuff TearsShoulder Disease
- Interventions
- Procedure: Conservative treatmentProcedure: Arthroscopic Decompression SurgeryProcedure: Reverse ProsthesisDrug: Pain-Relief MedicationDevice: Reverse Prosthesis Device
- Registration Number
- NCT05780229
- Lead Sponsor
- Parc de Salut Mar
- 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%.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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;
- Neurological injury.
- Active infection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Massive Rotator Cuff Tears: Mixed Methodology Conservative treatment 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. Massive Rotator Cuff Tears: Mixed Methodology Reverse Prosthesis Device 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. Massive Rotator Cuff Tears: Mixed Methodology Reverse Prosthesis 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. Massive Rotator Cuff Tears: Mixed Methodology Arthroscopic Decompression Surgery 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. Massive Rotator Cuff Tears: Mixed Methodology Pain-Relief Medication 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.
- Primary Outcome Measures
Name Time Method Relevant treatment outcome identified through the Phase 1 of the study. Before treatment "Fend for yourself" was identified in the Qualitative Phase as a relevant outcome. It was captured through a question before treatment: "To what extent are you able to fend for yourself".
Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study). At 6, 12, and 24 months after treatment "Fend for yourself" was identified in the Qualitative Phase as a relevant outcome, and was captured through two questions: A) "To what extent were you able to fend for yourself before the injury?"; and B) "To what extent can you fend for yourself after treatment?".
Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments Before and 6, 12, and 24 months after treatment The Oxford Shoulder Score (OSS) is a 12-item instrument assessing the impact of shoulder treatments and their outcomes. Response options for each OSS item are on a 4-level Likert scale, which ranges from 0 to 48, where higher scores indicate better outcomes.
- Secondary Outcome Measures
Name Time Method Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions Before and 6, 12, and 24 months after treatment The EuroQol-5D Dimensions (EQ-5D-5L) is a generic econometric instrument that contains five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity in each dimension. From the possible combinations of scales and severity levels (3125 health states), a utility index is obtained, which ranges from 1 (perfect health) to negative values, 0 being the value attributed to death.
Ability to carry out normal daily activities measured with the Constant-Murley Score Before and 6, 12, and 24 months after treatment The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters, which define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Trial Locations
- Locations (6)
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
🇪🇸Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Parc Taulí Hospital Universitari
🇪🇸Sabadell, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clínic
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain