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

Arthritis Clinical Trial

Official title:

Long Term Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983357
• Other study ID #: 0435-16-FB
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: May 11, 2018

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Long term outcome follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. This research will be a case series study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant. Eligibility criteria are subjects,who were treated at the Department of Orthopaedic Surgery at University of Nebraska Medical Center and Nebraska Medicine, with a total shoulder replacement using an anchor peg glenoid and autologous bone grafting, and who are now at least 9 years out from surgery. Each subject will be evaluated and this will include having three plain radiographs of the operated shoulder of which 2 will be true anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films. In addition, the subject will have a computed tomographic (CT) scan, without contrast dye, to examine the shoulder. One of the study personnel will use the Constant Score and Simple Shoulder Test to obtain specific shoulder functional, motion, and strength outcomes as well as pain assessment. A patient completed questionnaire, Rand Short Form Health Survey, (Rand SF-36) will be obtained to look at association with general health status. Investigators hypothesize that there will be a low incidence of glenoid loosening with a TSA (total shoulder arthroplasty) using an anchor peg glenoid and autologous bone grafting. In addition, investigators suggest that the absence of radiolucent lines will correlate with excellent shoulder function. A study was previously completed at our facility on same population at a minimum of 2 year follow up. At that time, and despite more than 10 years of widespread clinical use, no radiographic or clinical data existed regarding this unique component type. The findings from this prior study indicated that total shoulder arthroplasty (TSA) utilizing minimal glenoid peripheral peg cement and autologous reamings placed between radial fins of the central peg allowed host bone incorporation for the central peg and that better bone incorporation imparted fewer overall peg lucencies. The study findings were accepted for presentation at The American Academy of Orthopaedic Surgeons, 2010, New Orleans. Despite these positive findings, loosening rates could increase farther out from surgery, hence the purpose for the current proposed longer follow up study which is evaluation at a minimum of 9 years post surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 44 Years to 94 Years

Eligibility

Inclusion Criteria:

• Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.

Exclusion Criteria:

• Subjects who are unable to comprehend the consent form information. Pregnant women will be excluded from the study.

Related Conditions & MeSH terms

• Arthritis

Intervention

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.
• Questionnaire
Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores.	CT	Day One
Secondary	Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.	plain radiograph	Day One