NCT05780229

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.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Massive Rotator Cuff Tears
• Shoulder Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-03-27
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2023-03-22
• Last updated: 2025-06-03

Locations

6 sites across 1 country: Spain