Comparing treatments for massive rotator cuff tears
Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
Parc de Salut Mar · NCT05780229
This study is trying to find out which treatment works best for people with massive rotator cuff tears by looking at their experiences and comparing different options like surgery and conservative care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Parc de Salut Mar (other) |
| Locations | 6 sites (Sabadell, Barcelona and 5 other locations) |
| Trial ID | NCT05780229 on ClinicalTrials.gov |
What this trial studies
This study aims to identify important treatment outcomes for individuals with massive rotator cuff tears, focusing on patient experiences to enhance shared decision-making during consultations in Spain. It employs a mixed methodology, starting with qualitative interviews to gather insights on patient perceptions and expectations. Following this, a quantitative phase will compare the effectiveness of conservative treatment, arthroscopic decompression surgery, and reverse prosthesis based on patient-relevant outcomes and quality of life. The study involves participants from multiple hospitals across two autonomous communities in Spain.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 to 85 with a complete rupture of the rotator cuff tendons and no prior surgical treatment on the affected shoulder.
Not a fit: Patients with neurological injuries or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with massive rotator cuff tears.
How similar studies have performed: Other studies have shown success in comparing treatment outcomes for rotator cuff injuries, but this mixed methodology approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sabadell, Barcelona and 5 other locations
- Parc Taulí Hospital Universitari — Sabadell, Barcelona, Spain (RECRUITING)
- Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute — Barcelona, Spain (ACTIVE_NOT_RECRUITING)
- Hospital del Mar — Barcelona, Spain (RECRUITING)
- Hospital Clínic — Barcelona, Spain (RECRUITING)
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (RECRUITING)
- Hospital Universitario La Paz — Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Montse Ferrer Forés, MD, Ph.D. — IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.
- Study coordinator: Montse Ferrer, MD, Ph.D.
- Email: mferrer@imim.es
- Phone: +34 933 160 740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Massive Rotator Cuff Tears, Shoulder Disease, Mixed metholodgy, Comparative Effectiveness Research, Prosthesis, Arthroscopic Surgery, Conservative treatment