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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00670852
Other study ID # 0391-07-FB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2008
Est. completion date June 10, 2009

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date June 10, 2009
Est. primary completion date June 10, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
X-rays and CT scan
CT Scan x-rays

Locations

Country Name City State
United States University of Nebraska Medical Center, Dept Orthopaedic Surgery Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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