Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation
NCT02983357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15
Last updated 2023-09-29
Summary
The purpose of this study is to investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes. Investigators hypothesize that a glenoid anchor peg component fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate with excellent shoulder function. Glenoid component loosening remains a major concern following total shoulder arthroplasty and is the man reason for failure. Despite positive findings in the investigators previous study (same population at a minimum of 2 year post operative follow up), it is reasonable that loosening rates could increase with longer follow-up. This study will be a minimum of 7 year post operative follow up.
Conditions
Interventions
- RADIATION
-
CT, X-Ray
2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder.
- OTHER
-
Physical assessment
Physically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes.
- OTHER
-
Questionnaire
Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement
Sponsors & Collaborators
-
University of Nebraska
lead OTHER
Principal Investigators
-
Matthew J Teusink, MD · University of Nebraska
Eligibility
- Min Age
- 44 Years
- Max Age
- 94 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-11-01
- Primary Completion
- 2018-05-11
- Completion
- 2018-05-11
Countries
- United States
Study Locations
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