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Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes

Glenoid Bone Grafting for Reverse Shoulder Arthroplasty: Clinical and Radiographic Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03151109
Acronym
EPBG
Enrollment
67
Registered
2017-05-12
Start date
2016-09-01
Completion date
2021-06-30
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Shoulders

Keywords

reverse total shoulder arthroplasty, glenoid bone loss

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.

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.

Interventions

DIAGNOSTIC_TESTCT Scan

CT scan at minimum 1 year post op

Sponsors

Zimmer Biomet
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic Outcomeminimum 1 year post opEvaluate 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

MeasureTime frameDescription
Functional outcomes at year onecollected at 1 year post surgeryEvaluate postoperative clinical outcome scores
Functional outcomes at year twocollected 2 years post surgeryEvaluate postoperative clinical outcome scores

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026