NCT03425500

Brief Summary

To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

7.2 years

First QC Date

January 31, 2018

Last Update Submit

August 28, 2023

Conditions

Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (1)

  • Maintenance of Acromiohumeral Distance

    The primary objective of this study is to compare the effect between the two surgical techniques, arthroscopic SCR for a massive, chronic irreparable tear of the rotator cuff vs. BRR with an acellular human dermal allograft implant, on the maintenance of the Acromiohumeral distance. Acromiohumeral Distance is measured in mm and determine through xray.

    24 months

Secondary Outcomes (3)

  • Changes in Shoulder Strength After Surgery

    24 months

  • Changes in Shoulder Range of Motion After Surgery

    24 months

  • Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)

    24 months

Study Arms (2)

Bridging Rotator Cuff Group

EXPERIMENTAL

Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft.

Procedure: Bridging Rotator Cuff ReconstructionDevice: GRAFTJACKET™ allograft

Superior Capsular Group

ACTIVE COMPARATOR

Superior Capsular Reconstruction of massive rotator cuff tear

Procedure: Superior Capsular Reconstruction

Interventions

Bridging Rotator Cuff ReconstructionPROCEDURE

Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft

Bridging Rotator Cuff Group
Superior Capsular ReconstructionPROCEDURE

Superior Capsular Reconstruction of massive rotator cuff tear

Superior Capsular Group
GRAFTJACKET™ allograftDEVICE

The acellular human dermal allograft in used in the bridging rotator cuff reconstruction

Also known as: Acellular human dermal allograft
Bridging Rotator Cuff Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff

You may not qualify if:

  • Presence of subscapular tear
  • Presence of glenohumeral osteoarthritis
  • WORC score \> 70%
  • Uncontrolled diabetes
  • Pregnancy
  • Presence of local or systemic infection
  • Paralysis of the shoulder
  • Poor nutritional state
  • Contracture of the shoulder
  • Presence of cuff tear arthropathy
  • MRI proven nonvascular surgical sites
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E1, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Officials

  • Ivan H Wong, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon MD FRCS(C), Dip. Sports Medicine

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 7, 2018

Study Start

May 1, 2018

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

CA(1)