Humeral Head Implants: Radiological and Clinical Evaluation

Idiopathic Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02754024
• Other study ID #: HHI
• Status: Active, not recruiting
• Start date: September 2005
• Est. completion date: September 2025

Study information

• Verified date: July 2020
• Source: Austrian Research Group for Regenerative and Orthopedic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Total shoulder arthroplasty (TSA)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
• Hemi shoulder arthroplasty (HSA)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Werner Anderl

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Constant score	The Constant score is a validated outcome score assessing pain and function of the shoulder	5 years
Primary	Radiological assessment to determine radiolucent areas and osteolysis around the humeral head		5 years
Secondary	the Constant score		Change from baseline to 2 years postimplantation
Secondary	Radiological assessment to determine radiolucent areas and osteolysis around the humeral head		2 years
Secondary	the Constant score		Change from baseline to 5 years postimplantation
Secondary	the Constant score		10 years
Secondary	Radiological assessment to determine radiolucent areas and osteolysis around the humeral head		10 years
Secondary	the Constant score		15-20 years
Secondary	Radiological assessment to determine radiolucent areas and osteolysis around the humeral head		15-20 years