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.

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Disease; Massive Rotator Cuff Tears
• Intervention / Treatment: Procedure: Conservative treatment; Procedure: Arthroscopic Decompression Surgery; Procedure: Reverse Prosthesis; Drug: Pain-Relief Medication; Device: Reverse Prosthesis Device

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%.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Montse Ferrer, MD, Ph.D.; Phone Number: +34 933 160 740; Email: mferrer@imim.es
• Study Contact Backup: Name: Carlos Torrens, MD, Ph.D.; Email: ctorrens@psmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Carlos Torrens, MD, Ph.D.; Phone Number: +34 609 753 620; Email: ctorrens@psmar.cat
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic
    • Contact: Lluis Peidró, MD, Ph.D.; Email: lpeidro@clinic.cat
  • Barcelona, Spain, 08003
    • Active, not recruiting
    • Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Raúl Barco, MD; Email: raulbarco@hotmail.com
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
    • Contact: Emilio Calvo, MD, Ph.D.; Email: ecalvo@fjd.es
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Parc Tauli Hospital Universitari
      • Contact: Joan Miquel Noguera, MD; Email: joanmiquelnoguera@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with massive rotator cuff tears.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Conservative treatment; 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.; Other Names: Rehabilitation; Procedure: Arthroscopic Decompression Surgery; 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.; Procedure: Reverse Prosthesis; 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.; Drug: Pain-Relief Medication; 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.; Device: Reverse Prosthesis Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Hospital Clinic of Barcelona; Hospital Universitario Fundación Jiménez Díaz; Hospital Universitario La Paz; Parc Taulí Hospital Universitari
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prosthesis; Conservative treatment; Comparative Effectiveness Research; Massive Rotator Cuff Tears; Arthroscopic Surgery; Mixed metholodgy; Shoulder Disease
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: PI18/00152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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).
• IPD Sharing Access Criteria: Data sharing agreement among institutions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No