Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

Study Overview
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Brief Summary
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Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Detailed Description
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Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Official Title
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Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings

Conditions
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Rotator Cuff Arthropathy

Intervention / Treatment
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* Other: Reverse total shoulder replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years old Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven Primary indication for surgery is rotator cuff arthropathy Informed consent obtained Exclusion Criteria: Total shoulder replacement in post septic arthritis. Total shoulder replacement in post-instability arthritis. Revision total shoulder arthroplasty. Posttraumatic total shoulder arthroplasty (after failed index operation)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reverse total shoulder replacement<br>Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) | Other: Reverse total shoulder replacement<br>* Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder X-ray | To describe bony reaction at the bone-implant interface for the humeral component of a reverse shoulder arthroplasty. End-point radiographs will be compared to radiographs taken postoperatively in order to define stress shielding and/or bone resorption in the 5 humeral zones described by Nagels et al. | up to 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome | up to 20 months | 
| Constant-Murley score | To evaluate the functional state of the shoulder in patients with shoulder complaints | up to 20 months | 
| Short Form 36 Health Survey Questionnaire (SF-36) | To indicate the health status and pain scales | up to 20 months | 
| Net Promotor Score (NPS) | To evaluate patient satisfaction after surgery | one time visit | 
| Anchor Question Shoulder Score | To measure the change in general daily functioning and pain symptoms after shoulder surgery | up to 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reverse total shoulder arthroplasty