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Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries

Primary Purpose

Rotator Cuff Tears, Microfractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Greenhouse Technique
Microfracture Combined With Suture Bridge Technique
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 rotator cuff tear, Microfractures, greenhouse, Suture Bridge Technique

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
  • Between 20-65 years old

Exclusion Criteria:

  • Bilateral rotator cuff tear
  • Underwent ipsilateral surgery
  • Large-to-massive rotator cuff tear
  • Combined with Bankart, SLAP or AC lesion
  • Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Greenhouse group

    Vent group

    Arm Description

    Patients underwent greenhouse technique:The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used.

    The three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.

    Outcomes

    Primary Outcome Measures

    American Shoulder and Elbow Surgeons Shoulder (ASES) score
    A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
    American Shoulder and Elbow Surgeons Shoulder (ASES) score
    A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
    tendon integrity
    MRI was used to assess the integrity of the repaired rotator cuff tendon
    Visual Analogue Scale(VAS)
    A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
    Visual Analogue Scale(VAS)
    A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2020
    Last Updated
    December 28, 2020
    Sponsor
    Beijing Jishuitan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04686968
    Brief Title
    Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries
    Official Title
    Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2024 (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
    Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.
    Detailed Description
    Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tears, Microfractures
    Keywords
    rotator cuff tear, Microfractures, greenhouse, Suture Bridge Technique

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Greenhouse group
    Arm Type
    Experimental
    Arm Description
    Patients underwent greenhouse technique:The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used.
    Arm Title
    Vent group
    Arm Type
    Active Comparator
    Arm Description
    The three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.
    Intervention Type
    Procedure
    Intervention Name(s)
    Greenhouse Technique
    Intervention Description
    First, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor.
    Intervention Type
    Procedure
    Intervention Name(s)
    Microfracture Combined With Suture Bridge Technique
    Intervention Description
    A three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.
    Primary Outcome Measure Information:
    Title
    American Shoulder and Elbow Surgeons Shoulder (ASES) score
    Description
    A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
    Time Frame
    1 year postoperatively
    Title
    American Shoulder and Elbow Surgeons Shoulder (ASES) score
    Description
    A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
    Time Frame
    2 years postoperatively
    Title
    tendon integrity
    Description
    MRI was used to assess the integrity of the repaired rotator cuff tendon
    Time Frame
    1 year postoperatively
    Title
    Visual Analogue Scale(VAS)
    Description
    A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
    Time Frame
    1 year postoperatively
    Title
    Visual Analogue Scale(VAS)
    Description
    A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
    Time Frame
    2 year postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy Between 20-65 years old Exclusion Criteria: Bilateral rotator cuff tear Underwent ipsilateral surgery Large-to-massive rotator cuff tear Combined with Bankart, SLAP or AC lesion Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration
    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, M.D.
    Organizational Affiliation
    Sports Medicine Service, Beijing Jishuitan hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23522987
    Citation
    Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
    Results Reference
    background
    PubMed Identifier
    32976717
    Citation
    Kim C, Lee YJ, Kim SJ, Yoon TH, Chun YM. Bone Marrow Stimulation in Arthroscopic Repair for Large to Massive Rotator Cuff Tears With Incomplete Footprint Coverage. Am J Sports Med. 2020 Nov;48(13):3322-3327. doi: 10.1177/0363546520959314. Epub 2020 Sep 25.
    Results Reference
    background
    PubMed Identifier
    25487905
    Citation
    Taniguchi N, Suenaga N, Oizumi N, Miyoshi N, Yamaguchi H, Inoue K, Chosa E. Bone marrow stimulation at the footprint of arthroscopic surface-holding repair advances cuff repair integrity. J Shoulder Elbow Surg. 2015 Jun;24(6):860-6. doi: 10.1016/j.jse.2014.09.031. Epub 2014 Dec 2.
    Results Reference
    background

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    Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries

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