NCT02136251

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2015

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

May 8, 2014

Last Update Submit

August 10, 2023

Conditions

Arthritis

Keywords

Total Shoulder ArthroplastyGlenoid anchor peg component fixationAutologous bone grafting

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

shoulder replacement

Subjects who had shoulder replacement surgery at The University of Nebraska and The Nebraska Medical Center at least 5 or more years ago and autologous bone graft around the anchor-peg glenoid prosthesis was used.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Orthopaedic Surgery clinic patients

You may qualify if:

  • \- 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.

You may not qualify if:

  • unable to comprehend the consent form information
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Matthew Teusink, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

September 1, 2014

Primary Completion

February 13, 2015

Study Completion

February 13, 2015

Last Updated

August 14, 2023

Record last verified: 2023-08