ArthritisNCT02983357
Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation
An observational study of Arthritis, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is 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. Read more about this study
- Who is it for?
- Ages 44 to 94 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- CT, X-Ray, Physical assessment and Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 11 May 2018
- 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 44 to 94 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This research is a case series 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.
Who may be able to join
- Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.
Who cannot join
- Subjects who are unable to comprehend the consent form information. Pregnant women will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Long Term Outcome 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 (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes. Investigators hypothesize that a glenoid anchor peg component fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate with excellent shoulder function. Glenoid component loosening remains a major concern following total shoulder arthroplasty and is the man reason for failure. Despite positive findings in the investigators previous study (same population at a minimum of 2 year post operative follow up), it is reasonable that loosening rates could increase with longer follow-up. This study will be a minimum of 7 year post operative follow up.
Read the detailed description
Long term outcome follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. This research will be a case series 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 criteria are subjects,who were treated at the Department of Orthopaedic Surgery at University of Nebraska Medical Center and Nebraska Medicine, with a total shoulder replacement using an anchor peg glenoid and autologous bone grafting, and who are now at least 9 years out from surgery. Each subject will be evaluated and this will include having three plain radiographs of the operated shoulder of which 2 will be true anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films. In addition, the subject will have a computed tomographic (CT) scan, without contrast dye, to examine the shoulder. One of the study personnel will use the Constant Score and Simple Shoulder Test to obtain specific shoulder functional, motion, and strength outcomes as well as pain assessment. A patient completed questionnaire, Rand Short Form Health Survey, (Rand SF-36) will be obtained to look at association with general health status. Investigators hypothesize that there will be a low incidence of glenoid loosening with a TSA (total shoulder arthroplasty) using an anchor peg glenoid and autologous bone grafting. In addition, investigators suggest that the absence of radiolucent lines will correlate with excellent shoulder function. A study was previously completed at our facility on same population at a minimum of 2 year follow up. At that time, and despite more than 10 years of widespread clinical use, no radiographic or clinical data existed regarding this unique component type. The findings from this prior study indicated that total shoulder arthroplasty (TSA) utilizing minimal glenoid peripheral peg cement and autologous reamings placed between radial fins of the central peg allowed host bone incorporation for the central peg and that better bone incorporation imparted fewer overall peg lucencies. The study findings were accepted for presentation at The American Academy of Orthopaedic Surgeons, 2010, New Orleans. Despite these positive findings, loosening rates could increase farther out from surgery, hence the purpose for the current proposed longer follow up study which is evaluation at a minimum of 9 years post surgery.
- Conditions
- Arthritis
- Being tested
- CT, X-Ray, Physical assessment, Questionnaire
- Keywords
- Shoulder Arthroplasty, glenohumeral arthritis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT, X-RayRadiation
2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder.
Physical assessmentOther
Physically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes.
QuestionnaireOther
Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement
| Study group | Role | What they receive |
|---|---|---|
| Case Series Study | Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery. Receives: Radiation: CT, X-Ray; Other: Physical assessment; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores.
CT
Measured: Day One
Secondary outcomes (1)
Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.
plain radiograph
Measured: Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start1 Nov 2016
- Primary completion11 May 2018
- Study completion11 May 2018
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 only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Teusink, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983357
- Sponsor's protocol ID
- 0435-16-FB
- Status last verified
- Sep 2023
- First submitted
- 4 Nov 2016
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.
- ClinicalTrials.gov ID
- NCT02983357
- Acronym / sponsor ID
- 0435-16-FB
- Conditions
- Arthritis
- Keywords
- Shoulder Arthroplasty, glenohumeral arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 6 Dec 2016 (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.
The purpose of this study is 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. Investigators hypothesize that a glenoid anchor peg component fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate with excellent shoulder function. Glenoid component loosening remains a major concern following total shoulder arthroplasty and is the man reason for failure. Despite positive findings in the investigators previous study (same population at a minimum of 2 year post operative follow up), it is reasonable that loosening rates could increase with longer follow-up. This study will be a minimum of 7 year post operative follow up.
Detailed description
Long term outcome follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. This research will be a case series 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 criteria are subjects,who were treated at the Department of Orthopaedic Surgery at University of Nebraska Medical Center and Nebraska Medicine, with a total shoulder replacement using an anchor peg glenoid and autologous bone grafting, and who are now at least 9 years out from surgery. Each subject will be evaluated and this will include having three plain radiographs of the operated shoulder of which 2 will be true anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films. In addition, the subject will have a computed tomographic (CT) scan, without contrast dye, to examine the shoulder. One of the study personnel will use the Constant Score and Simple Shoulder Test to obtain specific shoulder functional, motion, and strength outcomes as well as pain assessment. A patient completed questionnaire, Rand Short Form Health Survey, (Rand SF-36) will be obtained to look at association with general health status. Investigators hypothesize that there will be a low incidence of glenoid loosening with a TSA (total shoulder arthroplasty) using an anchor peg glenoid and autologous bone grafting. In addition, investigators suggest that the absence of radiolucent lines will correlate with excellent shoulder function. A study was previously completed at our facility on same population at a minimum of 2 year follow up. At that time, and despite more than 10 years of widespread clinical use, no radiographic or clinical data existed regarding this unique component type. The findings from this prior study indicated that total shoulder arthroplasty (TSA) utilizing minimal glenoid peripheral peg cement and autologous reamings placed between radial fins of the central peg allowed host bone incorporation for the central peg and that better bone incorporation imparted fewer overall peg lucencies. The study findings were accepted for presentation at The American Academy of Orthopaedic Surgeons, 2010, New Orleans. Despite these positive findings, loosening rates could increase farther out from surgery, hence the purpose for the current proposed longer follow up study which is evaluation at a minimum of 9 years post surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Series Study | – | Radiation: CT, X-Ray, Other: Physical assessment, Other: QuestionnaireSubjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery. |
Who may qualify
- Ages
- 44 to 94 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This research is a case series 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.
Key inclusion criteria (1 listed)
- Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.
Key exclusion criteria (1 listed)
- Subjects who are unable to comprehend the consent form information. Pregnant women will be excluded from the 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 |
|---|---|---|
| CT, X-Ray2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder. | Radiation | Case Series Study |
| Physical assessmentPhysically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes. | Other | Case Series Study |
| QuestionnaireRand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement | Other | Case Series Study |
Primary outcome
Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores.
Time frame: Day One
CT
1 secondary outcome
Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.
Time frame: Day One
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 29 Sep 2023.
- Individual participant dataSharing planned: No
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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 J Teusink, 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 1 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 29 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?
Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores. (time frame: Day One). 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 29 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.