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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

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.

Condition or disease Intervention/treatment Phase
Arthropathy Shoulder Shoulder Pain Shoulder Osteoarthritis Shoulder Arthritis Shoulder Arthropathy Associated With Other Conditions Necrosis of Bone Arthritis Inflammatory Arthritis Device: ReUnion TSA, pegged design Device: ReUnion TSA, keeled design Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, 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.
Device: ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, 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.
Device: ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, 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.
Device: ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design




Primary Outcome Measures :
  1. Function of Subscapularis muscle as measured by belly-press test [ Time Frame: 5 years ]
  2. Radiographic loosening [ Time Frame: 5 years ]
    "glenoid at risk" proportion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03735173


Contacts
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Contact: Tram Nguyen 507-293-7923 Nguyen.Ngoc1@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tram Nguyen         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark Morrey, M.D. Mayo Clinic

Additional Information:
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Responsible Party: Mark E. Morrey, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03735173     History of Changes
Other Study ID Numbers: 17-011251
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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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

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Necrosis
Shoulder Pain
Joint Diseases
Osteonecrosis
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases