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NCT02136251 Clinical Trial

Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.

Arthritis Clinical Trial

— Glenoid  

Official title:
Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02136251
Other study ID # 0067-14-FB
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 2014
Est. completion date February 13, 2015

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.

Description:

This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 13, 2015
Est. primary completion date February 13, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago. Exclusion Criteria: - unable to comprehend the consent form information - pregnant women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs. 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. 5 years after surgery
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