Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement

Arthritis Clinical Trial

Official title:

Computed Tomographic and Functional Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670852
• Other study ID #: 0391-07-FB
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis

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.