Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.
Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
1 other identifier
observational
200
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2019
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJune 3, 2025
May 1, 2025
6.8 years
February 21, 2023
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (2)
Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
Before and 6, 12, and 24 months after treatment
Ability to carry out normal daily activities measured with the Constant-Murley Score
Before and 6, 12, and 24 months after treatment
Study Arms (1)
Massive Rotator Cuff Tears: Mixed Methodology
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.
Interventions
The rehabilitation is based on restoring the balance of the shoulder joint. Aiming to diminish pain and restore function, pain control and inflammation are addressed during the firsts 3-6 weeks. Before week 3, pendulum movements are allowed to initiate mobilization of the shoulder joint. Aiming to gain (almost) complete shoulder joint mobility, a passive and active mobility exercise program is carried out. Lastly, the focus is on muscle reinforcement, performing a series of active exercises with weights or bands to exercise different muscles of the shoulder or the shoulder girdle.
Arthroscopic decompression surgery of the rotator cuff tear consists of cleaning the subacromial space. The procedures that are sometimes performed to diminish pain may include, removing the inflamed bursa, releasing the long head of the biceps (if injured), or lightly burring the acromion bone under which the tendons slide.
The reverse prosthesis consists of shoulder articular joint replacement. The humeral head is sectioned, and, on the scapular side, a metal tray is placed, which is fixed with screws, and a metal half-sphere fixed to the metal tray. On the humeral side, a metal stem with a concave plastic component is placed to articulate with the metal half-sphere, allowing shoulder mobility without the need of rotator cuff muscles.
In the reverse prosthesis procedure and arthroscopic decompression surgery, the pain-relief medication plan is a standard regimen for all patients, which can be modified as needed. This plan is based on 50mg of dexketoprofeno, 1g of paracetamol, and 100mg of tramadol.
In the reverse prosthesis procedure, a Delta III reverse shoulder prosthesis is applied. The original design was developed by Grammont in 1980's, and has 2 components: 1) a metal tray fixed with screws, and a metal half-sphere fixed to the metal tray, and 2) a concave polyethylene component.
Eligibility Criteria
Patients with massive rotator cuff tears.
You may qualify if:
- 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;
You may not qualify if:
- Neurological injury.
- Active infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Parc de Salut Marlead
- Hospital Clinic of Barcelonacollaborator
- Hospital Universitario Fundación Jiménez Díazcollaborator
- Parc Taulí Hospital Universitaricollaborator
- Hospital Universitario La Pazcollaborator
Study Sites (6)
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208, Spain
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
Barcelona, 08003, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clínic
Barcelona, 08036, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Related Publications (1)
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.
PMID: 40223678RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Montse Ferrer Forés, MD, Ph.D.
IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.
- PRINCIPAL INVESTIGATOR
Carlos Torrens Cánovas, MD, Ph.D.
Hospital del Mar, 08003 Barcelona, Spain,
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 22, 2023
Study Start
March 27, 2019
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 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).
- Access Criteria
- Data sharing agreement among institutions.
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.