Superior Capsule vs Bridging Study (SCR)

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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Bridging; Procedure: SCR

Detailed Description

RCT n = 50

Groups:

1. bridging
2. SCR

Outcomes:

1. WORC
2. ASES
3. QuickDASH
4. MRI at 12 months post-op

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bridging; Tendon repair with graft interposition	Procedure: Bridging; Tendon repair with graft interposition
Experimental: SCR; Superior Capsule reconstruction	Procedure: SCR; Superior Capsule reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	24 months
Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	12 months
Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	6 months
Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	3 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	24 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	12 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	6 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	3 months
Tendon healing, assessed via MRI	Tendon healing (classifications: intact or retorn)	12 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Worker's Compensation Board of Alberta (funding); Canadian Orthopaedic Foundation (funding); Arthroscopy Association of North America (funding)
• Investigators: Principal Investigator: Ian Lo, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 7, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: irreparable
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: REB15-1787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No