200
Participants
Start Date
March 27, 2019
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2027
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.
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.
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.
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.
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.
Hospital Universitario Fundación Jiménez Díaz, Madrid
Hospital Universitario La Paz, Madrid
Parc Taulí Hospital Universitari, Sabadell
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona
Hospital del Mar, Barcelona
Hospital Clínic, Barcelona
Hospital Clinic of Barcelona
OTHER
Hospital Universitario Fundación Jiménez Díaz
OTHER
Parc Taulí Hospital Universitari
OTHER
Hospital Universitario La Paz
OTHER
Parc de Salut Mar
OTHER