Superior Capsule vs Bridging Study

NCT04965103 | Completed

• 1 other identifier: REB15-1787
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rotator Cuff Tears

Keywords

irreparable

Outcome Measures

Primary Outcomes (4)

• 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)

  24 months

• 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)

  12 months

• 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)

  6 months

• 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)

  3 months

Secondary Outcomes (9)

• Western Ontario Rotator Cuff Index

  24 months

• Western Ontario Rotator Cuff Index

  12 months

• Western Ontario Rotator Cuff Index

  6 months

• Western Ontario Rotator Cuff Index

  3 months

• Disabilities of the Arm, Shoulder and Hand - QuickDASH

  24 months

Study Arms (2)

Bridging

ACTIVE COMPARATOR

Tendon repair with graft interposition

Procedure: Bridging

SCR

EXPERIMENTAL

Superior Capsule reconstruction

Procedure: SCR

Interventions

SCR PROCEDURE

Superior Capsule reconstruction

SCR

Bridging PROCEDURE

Tendon repair with graft interposition

Bridging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Worker's Compensation Board of Alberta (funding): collaborator
• Canadian Orthopaedic Foundation (funding): collaborator
• Arthroscopy Association of North America (funding): collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Ian Lo, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and research assistant collecting outcomes were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 16, 2021
• Study Start: January 1, 2016
• Primary Completion: November 7, 2020
• Study Completion: December 31, 2020
• Last Updated: July 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share