Surgical Management of Irreparable RC Tears

Surgical Treatment of Massive and Irreparable Rotator Cuff Tears

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear

Detailed Description

Prospective, Non-Randomized Cohort Study The surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (Grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. Surgical options include arthroscopic superior capsular reconstruction (SCR), arthroscopic assisted latissimus dorsi transfer (aaLDT), or arthroscopic assisted lower trapezius transfer (aaLTT), with arthroscopic biceps tendoesis/tenotomy as a control group.

Each patient will receive an X-ray and MRI to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, AHI, CSA, Hamada grade, and arthritis grade.

Patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. Assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. Any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration.

Graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Sheila McRae, PhD; Phone Number: 204-925-7469; Email: smcrae@panamclinic.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3E4
      • Recruiting
      • Pan Am Clinic
      • Contact: Sheila McRae, MSc, PhD (C); Phone Number: 204-925-7469; Email: smcrae@panamclinic.com
      • Contact: Jeff Leiter, PhD; Phone Number: 204-925-2775; Email: jleiter@panamclinic.com
      • Principal Investigator: Peter B MacDonald, MD FRCSC

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Panam Clinic
• Collaborators: Pan Am Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: H2018:135

Drug and device information, study documents

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