ArthritisGlenoidNCT02136251
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
An observational study of Arthritis, run by University of Nebraska.
Trial summary
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to 13 Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthopaedic Surgery clinic patients
Who may be able to join
- Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago.
Who cannot join
- unable to comprehend the consent form information
- pregnant women
About this study
Official title: Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.
Read the detailed description
This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.
- Conditions
- Arthritis
- Keywords
- Total Shoulder Arthroplasty, Glenoid anchor peg component fixation, Autologous bone grafting
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| shoulder replacement | Subjects who had shoulder replacement surgery at The University of Nebraska and The Nebraska Medical Center at least 5 or more years ago and autologous bone graft around the anchor-peg glenoid prosthesis was used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs.
To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes.
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2014 (estimated)
- Primary completion13 Feb 2015
- Study completion13 Feb 2015
Why it stopped: Funding was not obtained to complete study
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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Teusink, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136251
- Sponsor's protocol ID
- 0067-14-FB
- Acronym
- Glenoid
- Status last verified
- Aug 2023
- First submitted
- 8 May 2014
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.
- ClinicalTrials.gov ID
- NCT02136251
- Acronym / sponsor ID
- Glenoid / 0067-14-FB
- Conditions
- Arthritis
- Keywords
- Total Shoulder Arthroplasty, Glenoid anchor peg component fixation, Autologous bone grafting
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding was not obtained to complete study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Sep 2014 (estimated)
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 12 May 2014 (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.
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.
Detailed description
This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder replacement | – | –Subjects who had shoulder replacement surgery at The University of Nebraska and The Nebraska Medical Center at least 5 or more years ago and autologous bone graft around the anchor-peg glenoid prosthesis was used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopaedic Surgery clinic patients
Key inclusion criteria (1 listed)
- Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago.
Key exclusion criteria (2 listed)
- unable to comprehend the consent form information
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs.
Time frame: 5 years after surgery
To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
Matthew Teusink, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by University of Nebraska.
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: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs. (time frame: 5 years after surgery). 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 14 Aug 2023.