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Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement (Glenoid)

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ClinicalTrials.gov Identifier: NCT00670852
Recruitment Status : Unknown
Verified April 2011 by University of Nebraska.
Recruitment status was:  Recruiting
First Posted : May 2, 2008
Last Update Posted : April 27, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with bony apposition on computed tomography scans, decreased radiolucent lines and component loosening, and functional outcomes. We hypothesize that by utilizing autologous bone graft from the resected humeral head, placed around the anchor peg glenoid prosthesis at implantation, there is a low incidence of glenoid loosening. We suggest that the absence of radiolucent lines correlated with excellent shoulder function.

Condition or disease Intervention/treatment
Arthritis Procedure: X-rays and CT scan

Detailed Description:
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.

Study Design

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Computed Tomographic and Functional Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty
Study Start Date : April 2008
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
I
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
CT Scan x-rays
Other Name: No names


Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: case study over approximate 3 months time. ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670852


Contacts
Contact: Dana Schwarz, R.N., M.S. 402-559-4167 dschwarz@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center - Dept of Orhtopaedic Surgery Recruiting
Omaha, Nebraska, United States, 68198-1080
Contact: Dana Schwarz, R.N., M.S.    402-559-4167    dschwarz@unmc.edu   
Principal Investigator: Edward Fehringer, M.D.         
University of Nebraska Medical Center, Dept. of Orthopaedic Surgery Recruiting
Omaha, Nebraska, United States, 68198-1080
Contact: Dana Schwarz, R.N., M.S.    402-559-4167    dschwarz@unmc.edu   
Principal Investigator: Edward Fehringer, M.D.         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Edward Fehringer, M.D. UNMC
More Information

Responsible Party: Edward Fehringer, M.D., UNMC
ClinicalTrials.gov Identifier: NCT00670852     History of Changes
Other Study ID Numbers: 391-07-FB
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: April 2011

Keywords provided by University of Nebraska:
Glenoid component
radiolucent lines
Glenoid loosening
glenohumeral arthritis
autologous bone graft

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases