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Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes (EPBG)

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ClinicalTrials.gov Identifier: NCT03151109
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study will look at patient radiographic and functional outcomes who have or will undergo a reverse, extended peg, shoulder arthroplasty (replacement) that requires the use of glenoid bone grafting.

Condition or disease Intervention/treatment
Osteo Arthritis Shoulders Diagnostic Test: CT Scan

Detailed Description:
Glenoid bone loss is a known issue with reverse shoulder implants and can lead to issues with implant fixation and stability over time. To address this issue an extended peg glenoid baseplate is used and area around plate is augmented with bone (auto or allo)graft material to encourage bony callous growth around the implant. This study is to look at this area of concern and determine if glenoid bone loss is occurring in the patients where these measures have been taken to deter its development.

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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Glenoid Bone Grafting for Reverse Shoulder Arthroplasty: Clinical and Radiographic Outcomes
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts


Intervention Details:
  • Diagnostic Test: CT Scan
    CT scan at minimum 1 year post op


Primary Outcome Measures :
  1. Radiographic Outcome [ Time Frame: minimum 1 year post op ]
    Evaluate Bone Graft Incorporation - review images to determine signs of humeral or glenoid radiolucency, radiographic loosening, fracture, notching, and graft incorporation versus resorption on CT and/or XRay images.


Secondary Outcome Measures :
  1. Functional outcomes at year one [ Time Frame: collected at 1 year post surgery ]
    Evaluate postoperative clinical outcome scores

  2. Functional outcomes at year two [ Time Frame: collected 2 years post surgery ]
    Evaluate postoperative clinical outcome scores



Information from the National Library of Medicine

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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
Patients with substantial glenoid bone loss in the context of severe glenohumeral arthrosis, advanced cuff tear arthropathy or those who have undergone prior shoulder arthroplasty and have or will undergo a reverse shoulder replacement with structural bone graft to address the problem.
Criteria

Inclusion Criteria:

  1. Adult patients who have undergone a reverse shoulder arthroplasty with the an extended peg baseplate and structural bone graft (autograft humeral head or allograft femoral head).
  2. Adult patients who are indicated for a long-pegged baseplate and glenoid bone grafting (autograft humeral head or allograft femoral head) as part of their reverse shoulder arthroplasty in our clinic,
  3. bone graft is truly structural involving at least 50% of the glenoid baseplate
  4. may be a primary or a revision surgery

Exclusion Criteria:

  1. patients with missing baseline (preop) data,
  2. patients who are unwilling to participate in a final follow-up evaluation.

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): NCT03151109


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Zimmer Biomet
Investigators
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Principal Investigator: Aaron Chamberlain, MD Washington University School of Medicine
Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03151109    
Other Study ID Numbers: 201507050
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
reverse total shoulder arthroplasty
glenoid bone loss
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases