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Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

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ClinicalTrials.gov Identifier: NCT03735173
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mark E. Morrey, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE November 8, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • Function of Subscapularis muscle as measured by belly-press test [ Time Frame: 5 years ]
  • Radiographic loosening [ Time Frame: 5 years ]
    "glenoid at risk" proportion
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03735173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Official Title  ICMJE Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Brief Summary Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthropathy Shoulder
  • Shoulder Pain
  • Shoulder Osteoarthritis
  • Shoulder Arthritis
  • Shoulder Arthropathy Associated With Other Conditions
  • Necrosis of Bone
  • Arthritis
  • Inflammatory Arthritis
Intervention  ICMJE
  • Device: ReUnion TSA, pegged design
    ReUnion total shoulder arthroplasty system, pegged design
  • Device: ReUnion TSA, keeled design
    ReUnion total shoulder arthroplasty system, keeled design
Study Arms  ICMJE
  • Active Comparator: Pegged through SP
    Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation.
    Intervention: Device: ReUnion TSA, pegged design
  • Active Comparator: Pegged through ST
    Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.
    Intervention: Device: ReUnion TSA, pegged design
  • Active Comparator: Keeled through SP
    Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation.
    Intervention: Device: ReUnion TSA, keeled design
  • Active Comparator: Keeled through ST
    Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.
    Intervention: Device: ReUnion TSA, keeled design
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects willing to sign the informed consent
  • Male and female subjects ages 18 - 90 at the time of surgery
  • Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)

Exclusion Criteria:

  • Inability to comply with follow-up requirements
  • Known or presumed substantial rotator cuff disorders
  • Subjects with an active or suspected latent infection in or about the shoulder
  • Subjects with instability (surgically or non-surgically addressed)
  • Subjects presenting with posttraumatic avascular necrosis
  • Need for glenoid bone grafting
  • Pregnant subjects
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tram Nguyen 507-293-7923 Nguyen.Ngoc1@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03735173
Other Study ID Numbers  ICMJE 17-011251
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark E. Morrey, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Morrey, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP