Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement (Glenoid)
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
Recruitment status was Recruiting
Sponsor:
University of Nebraska
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00670852
First received: April 30, 2008
Last updated: April 25, 2011
Last verified: April 2011
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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 (Adult, Senior) |
| 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
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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
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 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 |
| 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 September 23, 2016