Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Istituto Ortopedico Rizzoli
- Primary Endpoint
- Constant score
Study Overview
Brief Summary
The aim of the study is to document the clinical-radiological results from the case series of patients surgically treated for rotator cuff lesions from 2009 to 2020 at the Rizzoli Orthopaedic Institute Shoulder-Elbow Department.
Detailed Description
110 patients surgically treated for rotator cuff lesions from 2009 to 2020 will be included in a retrospective-prospective and interventional study with clinical and radiological evaluation at follow-up of at least 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥70 years of age at the time of rotator cuff repair surgery
- •Males and Females
- •Patients surgically treated for rotator cuff injury between 2009 and 2020 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute
Exclusion Criteria
- •All available patients will be invited to undergo clinical examination and radiological examination. In case some patients cannot undergo MRI due to possible contraindications, they will still be seen to collect the primary clinical outcome
Arms & Interventions
Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion
Evaluation of the clinical-radiological results from the case series of patients surgically treated for cuff rotator lesions from 2009 to 2020 at the Shoulder-Elbow Department . At 12 months the result is considered stabilized, so we will proceed to collect all case histories that have passed this follow-up period.
Intervention: MRI assessment (Radiation)
Outcomes
Primary Outcomes
Constant score
Time Frame: At least 12 months after cuff rotator lesion surgery
The constant score is the most commonly used questionnaire for evaluating treatment outcomes of shoulder disorders. It's the scoring system recommended by the European Society of Shoulder and Elbow Surgery (SECEC / ESSE). It has the advantages of including pain score, functional assessment, range of motion, and strength measures. A high score corresponds to a great quality of function
Secondary Outcomes
- Simple Shoulder Test (SST)(At least at leat 12 months after cuff rotator lesion surgery)
- Magnetic Resonance Imaging(At least 12 months after cuff rotator lesion surgery)
- Visual Analog Scale (VAS):(At least 12 months after cuff rotator lesion surgery)
- Short Form-12 (SF-12):(At least 12 months after cuff rotator lesion surgery)
- Treatment opinion post- surgery(At least 12 months after cuff rotator lesion surgery)