Superior Capsule vs Bridging Study

NCT ID: NCT04965103

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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RCT n = 50

Groups:

1. bridging
2. SCR

Outcomes:

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

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant and research assistant collecting outcomes were blinded.

Study Groups

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Bridging

Tendon repair with graft interposition

Group Type ACTIVE_COMPARATOR

Bridging

Intervention Type PROCEDURE

Tendon repair with graft interposition

SCR

Superior Capsule reconstruction

Group Type EXPERIMENTAL

SCR

Intervention Type PROCEDURE

Superior Capsule reconstruction

Interventions

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SCR

Superior Capsule reconstruction

Intervention Type PROCEDURE

Bridging

Tendon repair with graft interposition

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Worker's Compensation Board of Alberta (funding)

UNKNOWN

Sponsor Role collaborator

Canadian Orthopaedic Foundation (funding)

UNKNOWN

Sponsor Role collaborator

Arthroscopy Association of North America (funding)

UNKNOWN

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Lo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Other Identifiers

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REB15-1787

Identifier Type: -

Identifier Source: org_study_id

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