Humeral Head Implants: Radiological and Clinical Evaluation
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJuly 14, 2020
July 1, 2020
10.5 years
April 21, 2016
July 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
the Constant score
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
5 years
Secondary Outcomes (7)
the Constant score
Change from baseline to 2 years postimplantation
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
2 years
the Constant score
Change from baseline to 5 years postimplantation
the Constant score
10 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
10 years
- +2 more secondary outcomes
Study Arms (2)
Total shoulder arthroplasty (TSA)
Replacement of humeral head and glenoid
Hemi shoulder arthroplasty (HSA)
Replacement of humeral head only
Interventions
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
stemless humeral head implant
Eligibility Criteria
Patients requiring hemi- or total shoulder arthroplasty
You may qualify if:
- Age 40 to 85 years at time of surgery
- Patients with primary or secondary osteoarthritis of the shoulder
You may not qualify if:
- Patients with cuff tear arthropathy and axillary nerve lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Werner Anderllead
Related Publications (1)
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.
PMID: 29357861DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Member
Study Record Dates
First Submitted
April 21, 2016
First Posted
April 28, 2016
Study Start
September 1, 2005
Primary Completion
March 1, 2016
Study Completion
September 1, 2025
Last Updated
July 14, 2020
Record last verified: 2020-07