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Completed

NCT Number: NCT04965103

Superior Capsule vs Bridging Study

Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

RCT n = 50

Groups:

  • bridging
  • SCR

Outcomes:

  • WORC
  • ASES
  • QuickDASH
  • MRI at 12 months post-op

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCR

Procedure

Superior Capsule reconstruction

Bridging

Procedure

Tendon repair with graft interposition

Primary outcomes

  1. American Shoulder and Elbow Surgeon Outcome - patient portion

    Time frame: 24 months

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

  2. American Shoulder and Elbow Surgeon Outcome - patient portion

    Time frame: 12 months

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

  3. American Shoulder and Elbow Surgeon Outcome - patient portion

    Time frame: 6 months

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

  4. American Shoulder and Elbow Surgeon Outcome - patient portion

    Time frame: 3 months

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

Secondary outcomes

  1. Western Ontario Rotator Cuff Index

    Time frame: 24 months

    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

  2. Western Ontario Rotator Cuff Index

    Time frame: 12 months

    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

  3. Western Ontario Rotator Cuff Index

    Time frame: 6 months

    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

  4. Western Ontario Rotator Cuff Index

    Time frame: 3 months

    Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

  5. Disabilities of the Arm, Shoulder and Hand - QuickDASH

    Time frame: 24 months

    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)

  6. Disabilities of the Arm, Shoulder and Hand - QuickDASH

    Time frame: 12 months

    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)

  7. Disabilities of the Arm, Shoulder and Hand - QuickDASH

    Time frame: 6 months

    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)

  8. Disabilities of the Arm, Shoulder and Hand - QuickDASH

    Time frame: 3 months

    Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)

  9. Tendon healing, assessed via MRI

    Time frame: 12 months

    Tendon healing (classifications: intact or retorn)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Arthroscopy Association of North America
  • Canadian Orthopaedic Foundation (funding)
  • Worker's Compensation Board of Alberta (funding)

Registry information

Official study title

Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition

Acronym: SCR

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2021
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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