This is a 2 Year Follow up Clinical and Radiographic Analysis of a Novel All Polyethelene Glenoid Component in Standard Total Shoulder Arthroplasty.
1 other identifier
interventional
200
1 country
1
Brief Summary
Two hundred patients will be analyzed both clinically (via validated outcomes measures) and radiographically (via 2 sets of standard radiographs) to determine the survival and degree of bone in growth of a novel all polyethelene glenoid component used in a standard FDA approved shoulder arthroplasty system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMarch 14, 2011
March 1, 2011
1 year
March 10, 2011
March 10, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
ASES Scores
Accepted validated clinical outcome measure
Every 3 months
PENN Score
Accepted validated outcome measure
3 months
Radiographic integration of component
Two sets of radiographs will be obtained to look for any signs of loosening and for bony integration of the component
2 weeks, 6 weeks, 3 months, 2 years
Study Arms (1)
Single arm shoulder arthroplasty
EXPERIMENTALInterventions
Shoulder arthroplasty with anchor peg glenoid
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Knoxville Orthopaedic Clinic
Knoxville, Tennessee, 37922, United States
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2011
First Posted
March 14, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 14, 2011
Record last verified: 2011-03