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Humeral Head Implants: Radiological and Clinical Evaluation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02754024
Enrollment
100
Registered
2016-04-28
Start date
2005-09-30
Completion date
2025-09-30
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Stemless shoulder prosthesis

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.

Interventions

stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)

PROCEDUREHemi shoulder arthroplasty (HSA)

stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)

DEVICEEclipse™ (Arthrex Inc., Naples, FL, USA)

stemless humeral head implant

Sponsors

Werner Anderl
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the Constant score5 yearsThe 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 head5 years

Secondary

MeasureTime frame
the Constant scoreChange from baseline to 2 years postimplantation
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026