Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

Conditions
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Cuff Rotator Syndrome

Intervention / Treatment
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* Radiation: MRI assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion<br>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. | Radiation: MRI assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score | 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 | At least 12 months after cuff rotator lesion surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS): | Analogue scale represented by a line of 10 cm length, ranging from absence of pain to the worst imaginable pain  | At least 12 months after cuff rotator lesion surgery | 
| Simple Shoulder Test (SST) | 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 | At least at leat 12 months after cuff rotator lesion surgery | 
| Short Form-12 (SF-12): | 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. | At least 12 months after cuff rotator lesion surgery | 
| Treatment opinion post- surgery | Patient satisfaction with their post-surgery recovery status will be assessed. | At least 12 months after cuff rotator lesion surgery | 
| Magnetic Resonance Imaging | Magnetic Resonace Imaging will be carried for evaluating a possible plica retraction. | At least 12 months after cuff rotator lesion surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cuff rotator, retrospective study, prospective study, long-term clinical evaluation, long-term radiological evaluation