Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
- Conditions
- Cuff Rotator Syndrome
- Interventions
- Radiation: MRI assessment
- Registration Number
- NCT05082844
- Lead Sponsor
- Istituto Ortopedico Rizzoli
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion MRI assessment 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.
- Primary Outcome Measures
Name Time Method Constant score 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 Outcome Measures
Name Time Method Simple Shoulder Test (SST) At least at leat 12 months after cuff rotator lesion surgery SST test consists of 12 questions about physical functioning with dichotomous response options (yes or no). Scores range from 0 (worst) to 100 (best) and are reported as the percentage of items answered in the affirmative by the patient
Magnetic Resonance Imaging At least 12 months after cuff rotator lesion surgery Magnetic Resonace Imaging will be carried for evaluating a possible plica retraction.
Visual Analog Scale (VAS): At least 12 months after cuff rotator lesion surgery Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "
Short Form-12 (SF-12): At least 12 months after cuff rotator lesion surgery SF-12 serves as a generic indicator of quality of life and assesses the individual's subjective perception of health, understood as biopsychosocial well-being. Through 12 of the 36 questions of the original questionnaire, the SF-12 investigates 8 different aspects related to health status: physical activity, role limitations due to physical health, emotional state, physical pain, perception of general health status, vitality, social activities and mental health; the synthesis of the total scores allows to build two synthetic indices, a physical health index (PCS-12) and a mental health index (MCS-12). The lower the score of the two indices, indicatively below 20 points, the greater the level of disability.
Treatment opinion post- surgery At least 12 months after cuff rotator lesion surgery Patient satisfaction with their post-surgery recovery status will be assessed.