Humeral Head Implants: Radiological and Clinical Evaluation

Study Overview
=================
Brief Summary
-----------------
In the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. The aim of the present study is to report radiological and clinical outcome with a stemless shoulder implant with hollow screw fixation.

Conditions
-----------------
Idiopathic Osteoarthritis, Posttraumatic Osteoarthritis, Humeral Head Necrosis, Instability Arthritis

Intervention / Treatment
-----------------
* Procedure: Total shoulder arthroplasty (TSA)
* Procedure: Hemi shoulder arthroplasty (HSA)
* Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40 to 85 years at time of surgery Patients with primary or secondary osteoarthritis of the shoulder Exclusion Criteria: Patients with cuff tear arthropathy and axillary nerve lesions

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total shoulder arthroplasty (TSA)<br>Replacement of humeral head and glenoid | Procedure: Total shoulder arthroplasty (TSA)<br>* stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)<br>Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)<br>* stemless humeral head implant<br>|
| Hemi shoulder arthroplasty (HSA)<br>Replacement of humeral head only | Procedure: Hemi shoulder arthroplasty (HSA)<br>* stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)<br>Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)<br>* stemless humeral head implant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Constant score | The Constant score is a validated outcome score assessing pain and function of the shoulder | 5 years | 
| Radiological assessment to determine radiolucent areas and osteolysis around the humeral head |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Constant score |  | Change from baseline to 2 years postimplantation | 
| Radiological assessment to determine radiolucent areas and osteolysis around the humeral head |  | 2 years | 
| the Constant score |  | Change from baseline to 5 years postimplantation | 
| the Constant score |  | 10 years | 
| Radiological assessment to determine radiolucent areas and osteolysis around the humeral head |  | 10 years | 
| the Constant score |  | 15-20 years | 
| Radiological assessment to determine radiolucent areas and osteolysis around the humeral head |  | 15-20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stemless shoulder prosthesis