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
  Purpose

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 Intervention
Arthritis
Procedure: X-rays and CT scan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: April 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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.         
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.         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Edward Fehringer, M.D. UNMC
  More Information

No publications provided

Responsible Party: Edward Fehringer, M.D., UNMC
ClinicalTrials.gov Identifier: NCT00670852     History of Changes
Other Study ID Numbers: 391-07-FB
Study First Received: April 30, 2008
Last Updated: April 25, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014