Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation

NCT02983357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-09-29

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02983357 on ClinicalTrials.gov