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Superior Capsule vs Bridging Study (SCR)

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SCR
Bridging
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring irreparable

Eligibility Criteria

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

Inclusion Criteria:

  1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
  2. Either primary tear or re-tear after previous repair
  3. Radiographic evidence of Hamada stage 1-3, with or without Samilson & Prieto mild osteoarthritis (<3mm inferior osteophyte)

Exclusion Criteria:

  1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson & Prieto classification moderate or greater
  2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
  3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
  4. Medical issues precluding surgery
  5. Unwilling or unable to complete study outcomes
  6. Worker's Compensation Claim or litigation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Bridging

    SCR

    Arm Description

    Tendon repair with graft interposition

    Superior Capsule reconstruction

    Outcomes

    Primary Outcome Measures

    American Shoulder and Elbow Surgeon Outcome - patient portion
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    American Shoulder and Elbow Surgeon Outcome - patient portion
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    American Shoulder and Elbow Surgeon Outcome - patient portion
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    American Shoulder and Elbow Surgeon Outcome - patient portion
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)

    Secondary Outcome Measures

    Western Ontario Rotator Cuff Index
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Western Ontario Rotator Cuff Index
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Western Ontario Rotator Cuff Index
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Western Ontario Rotator Cuff Index
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Tendon healing, assessed via MRI
    Tendon healing (classifications: intact or retorn)

    Full Information

    First Posted
    June 21, 2021
    Last Updated
    July 6, 2021
    Sponsor
    University of Calgary
    Collaborators
    Worker's Compensation Board of Alberta (funding), Canadian Orthopaedic Foundation (funding), Arthroscopy Association of North America (funding)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04965103
    Brief Title
    Superior Capsule vs Bridging Study
    Acronym
    SCR
    Official Title
    Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    November 7, 2020 (Actual)
    Study Completion Date
    December 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Calgary
    Collaborators
    Worker's Compensation Board of Alberta (funding), Canadian Orthopaedic Foundation (funding), Arthroscopy Association of North America (funding)

    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
    Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.
    Detailed Description
    RCT n = 50 Groups: bridging SCR Outcomes: WORC ASES QuickDASH MRI at 12 months post-op

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tears
    Keywords
    irreparable

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Participant and research assistant collecting outcomes were blinded.
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bridging
    Arm Type
    Active Comparator
    Arm Description
    Tendon repair with graft interposition
    Arm Title
    SCR
    Arm Type
    Experimental
    Arm Description
    Superior Capsule reconstruction
    Intervention Type
    Procedure
    Intervention Name(s)
    SCR
    Intervention Description
    Superior Capsule reconstruction
    Intervention Type
    Procedure
    Intervention Name(s)
    Bridging
    Intervention Description
    Tendon repair with graft interposition
    Primary Outcome Measure Information:
    Title
    American Shoulder and Elbow Surgeon Outcome - patient portion
    Description
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    Time Frame
    24 months
    Title
    American Shoulder and Elbow Surgeon Outcome - patient portion
    Description
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    Time Frame
    12 months
    Title
    American Shoulder and Elbow Surgeon Outcome - patient portion
    Description
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    Time Frame
    6 months
    Title
    American Shoulder and Elbow Surgeon Outcome - patient portion
    Description
    American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Western Ontario Rotator Cuff Index
    Description
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Time Frame
    24 months
    Title
    Western Ontario Rotator Cuff Index
    Description
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Time Frame
    12 months
    Title
    Western Ontario Rotator Cuff Index
    Description
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Time Frame
    6 months
    Title
    Western Ontario Rotator Cuff Index
    Description
    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
    Time Frame
    3 months
    Title
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Description
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Time Frame
    24 months
    Title
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Description
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Time Frame
    12 months
    Title
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Description
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Time Frame
    6 months
    Title
    Disabilities of the Arm, Shoulder and Hand - QuickDASH
    Description
    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
    Time Frame
    3 months
    Title
    Tendon healing, assessed via MRI
    Description
    Tendon healing (classifications: intact or retorn)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively) Either primary tear or re-tear after previous repair Radiographic evidence of Hamada stage 1-3, with or without Samilson & Prieto mild osteoarthritis (<3mm inferior osteophyte) Exclusion Criteria: Primary glenohumeral osteoarthritis: radiographic evidence of Samilson & Prieto classification moderate or greater Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis) Medical issues precluding surgery Unwilling or unable to complete study outcomes Worker's Compensation Claim or litigation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ian Lo, MD
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan to share individual participant data.

    Learn more about this trial

    Superior Capsule vs Bridging Study

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