NCT03878862

Brief Summary

The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

7 years

First QC Date

March 15, 2019

Last Update Submit

April 1, 2024

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (5)

  • Visual analog scale for pain

    10 cm scale with 0 = no pain and 10= extreme pain

    24-months

  • Simple shoulder test

    A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12

    24-months

  • American Shoulder and Elbow Score

    Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome

    24-months

  • Veterans Rand - 12

    A validated general health survey with 0 as a poor outcome and 100 as a positive outcome.

    24-months

  • Western Ontario Rotator Cuff score

    A validated measure with 0 as a poor score and 100 as a positive score.

    24-months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting at the Pan Am Clinic to the contributing surgeons with an irreparable rotator cuff tear

You may qualify if:

  • massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting.
  • Definition of "irreparable": grade 3 or higher fatty infiltration into the infraspinatus

You may not qualify if:

  • Protected populations: prisoners, military, non-English speakers, age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

Sheila McRae, PhD

CONTACT

204-925-7469smcrae@panamclinic.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic surgeon

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 2, 2024

Record last verified: 2024-04

Locations

CA(1)