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Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears

Primary Purpose

Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
superior capsular reconstuction
partial rotator cuff repair
Sponsored by
Beijing Jishuitan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with Irreparable Rotator Cuff Tears
  • underwent superior capsular reconstruction or partial repair
  • at least two years follow-up

Exclusion Criteria:

  • reparable Rotator Cuff Tears
  • underwent reverse total shoulder arthroplasty

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    SCR group

    Partial group

    Arm Description

    underwent superior capsular reconstruction

    underwent partial rotator cuff repair

    Outcomes

    Primary Outcome Measures

    American Shoulder and Elbow Surgeons (ASES) score
    A patient-reported outcome measurement
    Acromiohumeral distance (AHD)
    measured in x-ray
    retear rate
    measured in MRI

    Secondary Outcome Measures

    Full Information

    First Posted
    October 7, 2020
    Last Updated
    October 7, 2020
    Sponsor
    Beijing Jishuitan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04584476
    Brief Title
    Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears
    Official Title
    Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears: A Prospective Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Jishuitan Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Rotator cuff tear is one of the common injuries that cause shoulder pain in the elderly. After the rotator cuff tendon is injured, repairing the torn rotator cuff tendon through arthroscopic surgery is an effective treatment that is currently widely used. In the rotator cuff injury, irreparable rotator cuff injury is a difficult point in treatment, especially for patients with a long injury time, the obvious shrinkage of the injured tendon, muscle atrophy and steatosis may occur, all of which lead to the poor quality of the rotator cuff tendon needed to be repaired , Poor healing ability, seriously affecting the shoulder joint function and daily life of these patients. For this part of patients, arthroscopic partial repair of torn rotator cuffs is one of the commonly used methods. In addition, in recent years, superior capsular reconstruction has been gradually applied to the clinic and has achieved good clinical effects, but there are no controlled studies to compare Clinical effect of partial repair and superior capsular reconstruction on irreparable rotator cuff injury.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tears
    Keywords
    Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SCR group
    Arm Type
    Experimental
    Arm Description
    underwent superior capsular reconstruction
    Arm Title
    Partial group
    Arm Type
    Other
    Arm Description
    underwent partial rotator cuff repair
    Intervention Type
    Procedure
    Intervention Name(s)
    superior capsular reconstuction
    Intervention Description
    these patients underwent arthroscopic superior capsular reconstuction
    Intervention Type
    Procedure
    Intervention Name(s)
    partial rotator cuff repair
    Intervention Description
    these patients underwent arthroscopic partial rotator cuff repair
    Primary Outcome Measure Information:
    Title
    American Shoulder and Elbow Surgeons (ASES) score
    Description
    A patient-reported outcome measurement
    Time Frame
    2 year postoperatively
    Title
    Acromiohumeral distance (AHD)
    Description
    measured in x-ray
    Time Frame
    1 year postoperatively
    Title
    retear rate
    Description
    measured in MRI
    Time Frame
    1 year postoperatively

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with Irreparable Rotator Cuff Tears underwent superior capsular reconstruction or partial repair at least two years follow-up Exclusion Criteria: reparable Rotator Cuff Tears underwent reverse total shoulder arthroplasty
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhijun Zhang, M.D.
    Phone
    +86 15201277648
    Email
    zzj5285029@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chunyan Jiang
    Organizational Affiliation
    Sports Medicine Service, Beijing Jishuitan hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears

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