ArthritisNCT00670852
Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement
An observational study of Arthritis, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- X-rays and CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2008to 10 Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients will be excluded if they are unable to comprehend the consent information.
- Pregnant women will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Dept Orthopaedic Surgery
Omaha, Nebraska, 68198-1080
About this study
Official title: Computed Tomographic and Functional Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty
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.
Read the detailed 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.
- Conditions
- Arthritis
- Being tested
- X-rays and CT scan
- Keywords
- Glenoid component, radiolucent lines, Glenoid loosening, glenohumeral arthritis, autologous bone graft
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rays and CT scanProcedure or surgery
Also called No names
CT Scan x-rays
| Study group | Role | What they receive |
|---|---|---|
| Total shoulder replacement with anchor peg glenoid and autologous bone grafting | 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. Receives: Procedure: X-rays and CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: case study over approximate 3 months time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study start1 Apr 2008
- Primary completion10 Jun 2009
- Study completion10 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Fehringer, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670852
- Sponsor's protocol ID
- 0391-07-FB
- Status last verified
- Sep 2023
- First submitted
- 30 Apr 2008
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomographic and Functional Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT00670852
- Acronym / sponsor ID
- 0391-07-FB
- Conditions
- Arthritis
- Keywords
- Glenoid component, radiolucent lines, Glenoid loosening, glenohumeral arthritis, autologous bone graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 10 Jun 2009 (actual)
- Study completion
- 10 Jun 2009 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total shoulder replacement with anchor peg glenoid and autologous bone grafting | – | Procedure: X-rays and CT scanPatients 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. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients will be excluded if they are unable to comprehend the consent information.
- Pregnant women will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-rays and CT scanAlso: No namesCT Scan x-rays | Procedure or surgery | Total shoulder replacement with anchor peg glenoid and autologous bone grafting |
Primary outcome
Autologous bone graft, anchor-peg glenoid prosthesis and functional outcomes
Time frame: case study over approximate 3 months time.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Fehringer, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autologous bone graft, anchor-peg glenoid prosthesis and functional outcomes (time frame: case study over approximate 3 months time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.