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Surgical Management of Irreparable RC Tears

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ClinicalTrials.gov Identifier: NCT03878862
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
Pan Am Clinic
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Treatment of Massive and Irreparable Rotator Cuff Tears
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Visual analog scale for pain [ Time Frame: 24-months ]
    10 cm scale with 0 = no pain and 10= extreme pain

  2. Simple shoulder test [ Time Frame: 24-months ]
    A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12

  3. American Shoulder and Elbow Score [ Time Frame: 24-months ]
    Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome

  4. Veterans Rand - 12 [ Time Frame: 24-months ]
    A validated general health survey with 0 as a poor outcome and 100 as a positive outcome.

  5. Western Ontario Rotator Cuff score [ Time Frame: 24-months ]
    A validated measure with 0 as a poor score and 100 as a positive score.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878862


Contacts
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Contact: Sheila McRae, PhD 204-925-7469 smcrae@panamclinic.com

Locations
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Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Contact: Sheila McRae, MSc, PhD (C)    204-925-7469    smcrae@panamclinic.com   
Contact: Jeff Leiter, PhD    204-925-2775    jleiter@panamclinic.com   
Principal Investigator: Peter B MacDonald, MD FRCSC         
Sponsors and Collaborators
Panam Clinic
Pan Am Clinic
More Information
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Responsible Party: Peter MacDonald, Orthopaedic surgeon, Panam Clinic
ClinicalTrials.gov Identifier: NCT03878862    
Other Study ID Numbers: H2018:135
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries