Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Relevant treatment outcome identified through the Phase 1 of the study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •Neurological injury.
- •Active infection.
研究组 & 干预措施
Massive Rotator Cuff Tears: Mixed Methodology
Phase 1: 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 in 5 Spanish hospitals.
Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals.
干预措施: Conservative treatment (Procedure)
Massive Rotator Cuff Tears: Mixed Methodology
Phase 1: 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 in 5 Spanish hospitals.
Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals.
干预措施: Arthroscopic Decompression Surgery (Procedure)
Massive Rotator Cuff Tears: Mixed Methodology
Phase 1: 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 in 5 Spanish hospitals.
Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals.
干预措施: Reverse Prosthesis (Procedure)
Massive Rotator Cuff Tears: Mixed Methodology
Phase 1: 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 in 5 Spanish hospitals.
Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals.
干预措施: Pain-Relief Medication (Drug)
Massive Rotator Cuff Tears: Mixed Methodology
Phase 1: 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 in 5 Spanish hospitals.
Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals.
干预措施: Reverse Prosthesis Device (Device)
结局指标
主要结局
Relevant treatment outcome identified through the Phase 1 of the study.
时间窗: 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).
时间窗: 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
时间窗: 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.
次要结局
- Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions(Before and 6, 12, and 24 months after treatment)
- Ability to carry out normal daily activities measured with the Constant-Murley Score(Before and 6, 12, and 24 months after treatment)