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

Active, not recruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

March 27, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Massive Rotator Cuff TearsShoulder 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.

Trial Locations (6)

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28046

Hospital Universitario La Paz, Madrid

08208

Parc Taulí Hospital Universitari, Sabadell

08003

Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona

Hospital del Mar, Barcelona

08036

Hospital Clínic, Barcelona

All Listed Sponsors
collaborator

Hospital Clinic of Barcelona

OTHER

collaborator

Hospital Universitario Fundación Jiménez Díaz

OTHER

collaborator

Parc Taulí Hospital Universitari

OTHER

collaborator

Hospital Universitario La Paz

OTHER

lead

Parc de Salut Mar

OTHER

NCT05780229 - Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology. | Biotech Hunter | Biotech Hunter