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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05082844
Enrollment
0
Registered
2021-10-19
Start date
2022-10-01
Completion date
2023-01-13
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cuff Rotator Syndrome

Keywords

cuff rotator, retrospective study, prospective study, long-term clinical evaluation, long-term radiological evaluation

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.

Interventions

RADIATIONMRI 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.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ≥70 years of age at the time of rotator cuff repair surgery 2. Males and Females 3. 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

Design outcomes

Primary

MeasureTime frameDescription
Constant scoreAt least 12 months after cuff rotator lesion surgeryThe 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

MeasureTime frameDescription
Visual Analog Scale (VAS):At least 12 months after cuff rotator lesion surgeryAnalogue scale represented by a line of 10 cm length, ranging from absence of pain to the worst imaginable pain
Simple Shoulder Test (SST)At least at leat 12 months after cuff rotator lesion surgerySST 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
Short Form-12 (SF-12):At least 12 months after cuff rotator lesion surgerySF-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- surgeryAt least 12 months after cuff rotator lesion surgeryPatient satisfaction with their post-surgery recovery status will be assessed.
Magnetic Resonance ImagingAt least 12 months after cuff rotator lesion surgeryMagnetic Resonace Imaging will be carried for evaluating a possible plica retraction.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026