Humeral Head Implants: Radiological and Clinical Evaluation

NCT ID: NCT02754024

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Idiopathic Osteoarthritis Posttraumatic Osteoarthritis Humeral Head Necrosis Instability Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Total shoulder arthroplasty (TSA)

Replacement of humeral head and glenoid

Total shoulder arthroplasty (TSA)

Intervention Type PROCEDURE

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

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

Intervention Type DEVICE

stemless humeral head implant

Hemi shoulder arthroplasty (HSA)

Replacement of humeral head only

Hemi shoulder arthroplasty (HSA)

Intervention Type PROCEDURE

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

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

Intervention Type DEVICE

stemless humeral head implant

Interventions

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Total shoulder arthroplasty (TSA)

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

Intervention Type PROCEDURE

Hemi shoulder arthroplasty (HSA)

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

Intervention Type PROCEDURE

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

stemless humeral head implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Werner Anderl

OTHER

Sponsor Role lead

Responsible Party

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Werner Anderl

Member

Responsibility Role SPONSOR_INVESTIGATOR

References

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Heuberer PR, Brandl G, Pauzenberger L, Laky B, Kriegleder B, Anderl W. Radiological changes do not influence clinical mid-term outcome in stemless humeral head replacements with hollow screw fixation: a prospective radiological and clinical evaluation. BMC Musculoskelet Disord. 2018 Jan 22;19(1):28. doi: 10.1186/s12891-018-1945-6.

Reference Type DERIVED
PMID: 29357861 (View on PubMed)

Other Identifiers

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HHI

Identifier Type: -

Identifier Source: org_study_id

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