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Clinical Trials/NCT03151109
NCT03151109
Completed
Not Applicable

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

Washington University School of Medicine1 site in 1 country67 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteo Arthritis Shoulders
Sponsor
Washington University School of Medicine
Enrollment
67
Locations
1
Primary Endpoint
Radiographic Outcome
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
June 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Functional outcomes at year two(collected 2 years post surgery)
  • Functional outcomes at year one(collected at 1 year post surgery)

Study Sites (1)

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