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NCT Number: NCT05780229

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Massive Rotator Cuff Tears Shoulder Disease

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain

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About this study

Primary Objectives:

Phase 1 (Qualitative):

  • To explore the perceptions, believes, experiences and coping strategies that are relevant results for people undergoing treatment of massive rotator cuff tears.
  • 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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 65 and 85 years.
  • No previous surgical treatment in the affected shoulder.
  • Complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging;

Exclusion criteria

  • Neurological injury.
  • Active infection.

Treatment and study plan

Conservative treatment

Procedure

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.

Other names: Rehabilitation

Arthroscopic Decompression Surgery

Procedure

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

Procedure

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

Drug

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

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.

Primary outcomes

  1. Relevant treatment outcome identified through the Phase 1 of the study.

    Time frame: 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".

  2. Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study).

    Time frame: 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?".

  3. Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments

    Time frame: 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.

Secondary outcomes

  1. Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions

    Time frame: Before and 6, 12, and 24 months after treatment

    The EuroQol-5D Dimensions (EQ-5D-5L) is a generic econometric instrument that contains five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity in each dimension. From the possible combinations of scales and severity levels (3125 health states), a utility index is obtained, which ranges from 1 (perfect health) to negative values, 0 being the value attributed to death.

  2. Ability to carry out normal daily activities measured with the Constant-Murley Score

    Time frame: Before and 6, 12, and 24 months after treatment

    The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters, which define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario La Paz
  • Parc Taulí Hospital Universitari

Registry information

Official study title

Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Mar 22, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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