Humeral Head Implants: Radiological and Clinical Evaluation

July 11, 2020 updated by: Werner Anderl
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients requiring hemi- or total shoulder arthroplasty

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total shoulder arthroplasty (TSA)
Replacement of humeral head and glenoid
Procedure: Total shoulder arthroplasty (TSA)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)
stemless humeral head implant
Hemi shoulder arthroplasty (HSA)
Replacement of humeral head only
Device: Eclipse™ (Arthrex Inc., Naples, FL, USA)
stemless humeral head implant
Procedure: Hemi shoulder arthroplasty (HSA)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Constant score
Time Frame: 5 years
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
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Werner Anderl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 11, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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