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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Relevant treatment outcome identified through the Phase 1 of the study. — Before treatment
  "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".
• Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study). — At 6, 12, and 24 months after treatment
  "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?".
• Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments — Before and 6, 12, and 24 months after treatment
  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.

Trial sites (6)

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