Recruiting

Surgical Management

Sponsor:

Panam Clinic

Code:

NCT03878862

Conditions

Rotator Cuff Tear

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Rotator Cuff Tear

Study ID

NCT03878862

Start date

Apr 1, 2019

Status verified date

Apr, 2024

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Visual analog scale for pain [ Time Frame: 24-months ]
  • Simple shoulder test [ Time Frame: 24-months ]
  • American Shoulder and Elbow Score [ Time Frame: 24-months ]
  • Veterans Rand - 12 [ Time Frame: 24-months ]
  • Western Ontario Rotator Cuff score [ Time Frame: 24-months ]

Central Contacts and Locations

Central contacts

Sheila McRae, PhD

204-925-7469smcrae@panamclinic.com

Locations

Pan Am Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3M 3E4

Contacts

Sheila McRae, MSc, PhD (C)

204-925-7469smcrae@panamclinic.com

Jeff Leiter, PhD

204-925-2775jleiter@panamclinic.com

Principal Investigator:

Peter B MacDonald, MD FRCSC

More Information

Sponsor

Panam Clinic

Last update posted

Apr 2, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Panam Clinic on 2024-04-02.