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

NCT02983357 | Completed

• 1 other identifier: 0435-16-FB
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Arthritis

Keywords

Shoulder Arthroplasty; glenohumeral arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.

  Day One

Study Arms (1)

Case Series Study

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.

Radiation: CT, X-Ray; Other: Physical assessment; Other: Questionnaire

Interventions

CT, X-Ray RADIATION

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.

Case Series Study

Physical assessment OTHER

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.

Case Series Study

Questionnaire OTHER

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

Case Series Study

Eligibility Criteria

• Age: 44 Years - 94 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This research is 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

X-Rays; Restraint, Physical; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Matthew J Teusink, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: December 6, 2016
• Study Start: November 1, 2016
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)