Overview

This trial is active, not recruiting.

Conditions idiopathic osteoarthritis, posttraumatic osteoarthritis, humeral head necrosis, instability arthritis
Treatments total shoulder arthroplasty (tsa), hemi shoulder arthroplasty (hsa)
Sponsor Werner Anderl
Start date September 2005
End date March 2016
Trial size 100 participants
Trial identifier NCT02754024, HHI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Replacement of humeral head and glenoid
total shoulder arthroplasty (tsa)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
Replacement of humeral head only
hemi shoulder arthroplasty (hsa)
stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)

Primary Outcomes

Measure
the Constant score
time frame: 5 years
Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
time frame: 5 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - Age 40 years and 85 at time of surgery - Patients with primary or secondary osteoarthritis of the shoulder Exclusion Criteria: - Patients with cuff tear arthropathy and axillary nerve lesions

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Austrian Research Group for Regenerative and Orthopedic Medicine.