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

Primary Purpose

Cuff Rotator Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI assessment
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cuff Rotator Syndrome focused on measuring cuff rotator, retrospective study, prospective study, long-term clinical evaluation, long-term radiological evaluation

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Visual Analog Scale (VAS):
    Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "
    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
    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.
    Treatment opinion post- surgery
    Patient satisfaction with their post-surgery recovery status will be assessed.
    Magnetic Resonance Imaging
    Magnetic Resonace Imaging will be carried for evaluating a possible plica retraction.

    Full Information

    First Posted
    August 9, 2021
    Last Updated
    May 9, 2023
    Sponsor
    Istituto Ortopedico Rizzoli
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05082844
    Brief Title
    Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
    Official Title
    Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Institutional research funds needed to perform imaging examinations under the study protocol have expired due to organizational issues
    Study Start Date
    October 1, 2022 (Actual)
    Primary Completion Date
    January 13, 2023 (Actual)
    Study Completion Date
    January 13, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Ortopedico Rizzoli

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cuff Rotator Syndrome
    Keywords
    cuff rotator, retrospective study, prospective study, long-term clinical evaluation, long-term radiological evaluation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion
    Arm Type
    Experimental
    Arm Description
    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 Type
    Radiation
    Intervention Name(s)
    MRI assessment
    Intervention Description
    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 Measure Information:
    Title
    Constant score
    Description
    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
    Time Frame
    At least 12 months after cuff rotator lesion surgery
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS):
    Description
    Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "
    Time Frame
    At least 12 months after cuff rotator lesion surgery
    Title
    Simple Shoulder Test (SST)
    Description
    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
    Time Frame
    At least at leat 12 months after cuff rotator lesion surgery
    Title
    Short Form-12 (SF-12):
    Description
    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.
    Time Frame
    At least 12 months after cuff rotator lesion surgery
    Title
    Treatment opinion post- surgery
    Description
    Patient satisfaction with their post-surgery recovery status will be assessed.
    Time Frame
    At least 12 months after cuff rotator lesion surgery
    Title
    Magnetic Resonance Imaging
    Description
    Magnetic Resonace Imaging will be carried for evaluating a possible plica retraction.
    Time Frame
    At least 12 months after cuff rotator lesion surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30572822
    Citation
    Longo UG, Margiotti K, Petrillo S, Rizzello G, Fusilli C, Maffulli N, De Luca A, Denaro V. Genetics of rotator cuff tears: no association of col5a1 gene in a case-control study. BMC Med Genet. 2018 Dec 20;19(1):217. doi: 10.1186/s12881-018-0727-1.
    Results Reference
    background
    PubMed Identifier
    7600171
    Citation
    Hattrup SJ. Rotator cuff repair: relevance of patient age. J Shoulder Elbow Surg. 1995 Mar-Apr;4(2):95-100. doi: 10.1016/s1058-2746(05)80061-8.
    Results Reference
    background
    PubMed Identifier
    23738239
    Citation
    Merolla G, Paladini P, Saporito M, Porcellini G. Conservative management of rotator cuff tears: literature review and proposal for a prognostic. Prediction Score. Muscles Ligaments Tendons J. 2011 Oct 30;1(1):12-9. Print 2011 Jan.
    Results Reference
    background
    PubMed Identifier
    11372355
    Citation
    Yamaguchi K. Mini-open rotator cuff repair: an updated perspective. Instr Course Lect. 2001;50:53-61.
    Results Reference
    background
    PubMed Identifier
    23365029
    Citation
    Robinson PM, Wilson J, Dalal S, Parker RA, Norburn P, Roy BR. Rotator cuff repair in patients over 70 years of age: early outcomes and risk factors associated with re-tear. Bone Joint J. 2013 Feb;95-B(2):199-205. doi: 10.1302/0301-620X.95B2.30246.
    Results Reference
    background
    PubMed Identifier
    26328240
    Citation
    Geary MB, Elfar JC. Rotator Cuff Tears in the Elderly Patients. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):220-4. doi: 10.1177/2151458515583895.
    Results Reference
    background
    PubMed Identifier
    20206038
    Citation
    Charousset C, Bellaiche L, Kalra K, Petrover D. Arthroscopic repair of full-thickness rotator cuff tears: is there tendon healing in patients aged 65 years or older? Arthroscopy. 2010 Mar;26(3):302-9. doi: 10.1016/j.arthro.2009.08.027.
    Results Reference
    background
    PubMed Identifier
    25834140
    Citation
    Bhatia S, Greenspoon JA, Horan MP, Warth RJ, Millett PJ. Two-Year Outcomes After Arthroscopic Rotator Cuff Repair in Recreational Athletes Older Than 70 Years. Am J Sports Med. 2015 Jul;43(7):1737-42. doi: 10.1177/0363546515577623. Epub 2015 Apr 1.
    Results Reference
    background

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

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