Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.

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.

Conditions

• Massive Rotator Cuff Tears
• Shoulder Disease

Interventions

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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Universitario Fundación Jiménez Díaz

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Parc de Salut Mar

  lead OTHER

Principal Investigators

• Montse Ferrer Forés, MD, Ph.D. · IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.

• Carlos Torrens Cánovas, MD, Ph.D. · Hospital del Mar, 08003 Barcelona, Spain,

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-27

Primary Completion

2025-12-31

Completion

2027-12-31

Countries

• Spain

Study Locations