RECRUITING

Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.

Official Title

Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears

Quick Facts

Study Start:2020-11-24
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04742452

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age range: ≥18 years
  2. * Irreparable rotator cuff tear suspected on pre-operative MRI
  1. * Pregnant, illiterate, or non-English speaking individuals
  2. * Rotator cuff pathology amenable to a complete repair intraoperatively
  3. * Moderate to severe rotator cuff arthropathy (Hamada grade ≥3)
  4. * Presence of glenohumeral arthritis on radiographs
  5. * Irreparable subscapularis muscle intraoperatively
  6. * Active infection within the ipsilateral glenohumeral joint
  7. * Neurologic pathology limiting shoulder function
  8. * Current smoker
  9. * Workers' compensation claim

Contacts and Locations

Study Contact

John T Strony, BS
CONTACT
908-268-3663
john.strony@uhhospitals.org

Study Locations (Sites)

Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Lake Health
Willoughby, Ohio, 44094
United States

Collaborators and Investigators

Sponsor: Robert J. Gillespie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-24
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2020-11-24
Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

  • Superior capsular reconstruction
  • Partial rotator cuff repair
  • Magnetic resonance imaging

Additional Relevant MeSH Terms

  • Rotator Cuff Tears