NCT00670852

Brief Summary

This is a case 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2009

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

April 30, 2008

Last Update Submit

September 21, 2023

Conditions

Keywords

Glenoid componentradiolucent linesGlenoid looseningglenohumeral arthritisautologous bone graft

Outcome Measures

Primary Outcomes (1)

  • Autologous bone graft, anchor-peg glenoid prosthesis and functional outcomes

    To determine if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlate with bony apposition on computed tomography scans, decreased radiolucent lines and component loosening, and functional outcomes.

    case study over approximate 3 months time.

Study Arms (1)

Total shoulder replacement with anchor peg glenoid and autologous bone grafting

Patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study.

Procedure: X-rays and CT scan

Interventions

CT Scan x-rays

Also known as: No names
Total shoulder replacement with anchor peg glenoid and autologous bone grafting

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Maximum number will be 70. Patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study.

You may qualify if:

  • Patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study.

You may not qualify if:

  • Patients will be excluded if they are unable to comprehend the consent information.
  • Pregnant women will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Dept Orthopaedic Surgery

Omaha, Nebraska, 68198-1080, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Edward Fehringer, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

April 1, 2008

Primary Completion

June 10, 2009

Study Completion

June 10, 2009

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations