Shoulder Disease Clinical Trial
Official title:
Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute | Barcelona | |
Spain | Hospital Clínic | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Parc Taulí Hospital Universitari | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar | Hospital Clinic of Barcelona, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario La Paz, Parc Taulí Hospital Universitari |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relevant treatment outcome identified through the Phase 1 of the study. | "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". | Before treatment | |
Primary | Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study). | "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?". | At 6, 12, and 24 months after treatment | |
Primary | Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments | 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. | Before and 6, 12, and 24 months after treatment | |
Secondary | Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions | 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. | Before and 6, 12, and 24 months after treatment | |
Secondary | Ability to carry out normal daily activities measured with the Constant-Murley Score | 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. | Before and 6, 12, and 24 months after treatment |
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