Humeral Head Implants: Radiological and Clinical Evaluation

Active, not recruiting

• Conditions: Posttraumatic Osteoarthritis; Humeral Head Necrosis; Idiopathic Osteoarthritis; Instability Arthritis

• Registration Number: NCT02754024
• Lead Sponsor: Werner Anderl

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2016-03
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-11
• Last Update Posted: 2020-07-14
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Constant score	5 years	The Constant score is a validated outcome score assessing pain and function of the shoulder
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head	5 years

Secondary Outcome Measures

Name	Time	Method
the Constant score	15-20 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head	15-20 years