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Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00670852
First received: April 30, 2008
Last updated: April 25, 2011
Last verified: April 2011
History of Changes

April 30, 2008
April 25, 2011
April 2008
September 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00670852 on ClinicalTrials.gov Archive Site
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Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement
Computed Tomographic and Functional Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

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.
Arthritis
Procedure: X-rays and CT scan
CT Scan x-rays
Other Name: No names
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.
Intervention: Procedure: X-rays and CT scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
19 Years to 90 Years
Yes
Contact: Dana Schwarz, R.N., M.S. 402-559-4167 dschwarz@unmc.edu
United States
 
NCT00670852
391-07-FB
No
Edward Fehringer, M.D., UNMC
University of Nebraska
Not Provided
Principal Investigator: Edward Fehringer, M.D. UNMC
University of Nebraska
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP