Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes

Completed

• Conditions: Osteo Arthritis Shoulders

• Registration Number: NCT03151109
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic Outcome	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

Name	Time	Method
Functional outcomes at year two	collected 2 years post surgery	Evaluate postoperative clinical outcome scores
Functional outcomes at year one	collected at 1 year post surgery	Evaluate postoperative clinical outcome scores

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States