A Randomized Multicenter Study Comparing the Effectiveness of Hemi- Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease

Not Applicable

Recruiting

Conditions: M19.91
M15
M15-M19
Polyarthrosis
Arthrosis

Registration Number: DRKS00003072

Lead Sponsor: AO Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 94

Inclusion Criteria

•Age 18 years and older
•Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)
•Glenoid morphologic type A1, A2 or B1 according to Walch
•Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
•Written informed consent

Exclusion Criteria

Preoperative:

* Posttraumatic omarthrosis
* Biconcave aspect of glenoid (Walch type B2)
* Retroversion of glenoid more than 25° (Walch type C)
* Epoca Reko prosthesis
* Humerus fractures
* Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)
* Substance abuse that would preclude reliable assessment
* Pregnancy
* Prisoners
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Intraoperative:

* Full thickness tear of rotator cuff
* Indication for hemiarthroplasty only
* Indication for total arthroplasty only
* Intraoperative decision to use implants other than Epoca

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Constant score assessment of shoulder function and pain [ Time Frame: Baseline to 5 years postsurgery ]<br>The primary outcome measure is the difference between the Constant score assessment of shoulder function and pain at baseline and 5 years after surgery. This difference is assessed for each individual patient.

Secondary Outcome Measures

Name	Time	Method
# Constant score [ Time Frame: 6 months, 1 year, 3 years ]<br># Shoulder Pain and Disability Index (SPADI) [ Time Frame: 6 months, 1 year, 3 years, 5 years ]<br><br># Duration of surgery [ Time Frame: 1-2 days ] [ <br><br># Numbers of adverse events [ Time Frame: Baseline to 5 years follow-up ] <br><br># Survivorship of implants [ Time Frame: Baseline to 5 years follow-up ] <br><br># Quality of life [ Time Frame: Baseline, 6 months, 1 year, 3 years, 5 years ]<br><br>Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire