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Completed

NCT Number: NCT03151109

Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes

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.

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Key information

Conditions

Osteo Arthritis Shoulders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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,
  • bone graft is truly structural involving at least 50% of the glenoid baseplate
  • may be a primary or a revision surgery

Exclusion criteria

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

Treatment and study plan

CT Scan

Diagnostic Test

CT scan at minimum 1 year post op

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

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

Acronym: EPBG

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 12, 2017
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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