search
Back to results

A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear

Primary Purpose

Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fascia lata allograft
human dermal allograft
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, Fascia lata allograft, human dermal allograft

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with irreparable rotator cuff tears
  • Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
  • At least two years follow-up

Exclusion Criteria:

  • reparable rotator cuff tears
  • underwent partial repair or reverse total shoulder arthroplasty

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Fascia lata group

    Dermal allograft group

    Arm Description

    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
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04587037
    Brief Title
    A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear
    Official Title
    A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear
    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
    Biomechanical and clinical success of the superior capsule reconstruction (SCR) using fascia lata (FL) grafts has been reported in treating irreparable rotator cuff tear. Human dermal (HD) allograft has been used successfully for SCRs; however, the clinical comparative study between FL and HD have not been reported.

    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, Fascia lata allograft, human dermal allograft

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Fascia lata group
    Arm Type
    Experimental
    Arm Title
    Dermal allograft group
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    fascia lata allograft
    Intervention Description
    underwent superior capsule reconstruction using fascia lata allograft
    Intervention Type
    Procedure
    Intervention Name(s)
    human dermal allograft
    Intervention Description
    underwent superior capsule reconstruction using human dermal allograft
    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 capsule reconstruction using fascia lata allograft with human dermal allograft At least two years follow-up Exclusion Criteria: reparable rotator cuff tears underwent partial repair or 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

    A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear

    We'll reach out to this number within 24 hrs