Hip ArthroplastyNCT01366911
Stem Cells Predicting Orthopedic Outcomes
An observational study of Hip Arthroplasty, run by University of Nebraska at 1 site in United States.
Trial summary
This is a pilot study to provide preliminary data of the association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays, obtained at time of surgery, and to begin… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Arthroplasty
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2011to 10 Jan 2014
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Orthopaedic surgical patients at specific clinic
Who may be able to join
- subjects who previously had a total hip arthroplasty and had stem cell assays completed on excess bone marrow
Who cannot join
- Subjects who do not wish to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Orthopaedic Surgery
Omaha, Nebraska, 68198
About this study
Official title: Can Stem Cells Predict Orthopaedic Outcomes? The Correlation of Bone Density Findings Post Total Hip Arthoplasty With Stem Cell Assays Obtaned at Time of Surgery
This is a pilot study to provide preliminary data of the association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays, obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic surgical outcomes.
Read the detailed description
Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs.
This ability to identify older individuals with compromised stem cell function could offer opportunities to develop and test new preventative and therapeutic strategies to improve outcomes.
- Conditions
- Hip Arthroplasty
- Keywords
- stem cells, QCT testing, Bone density findings, mesenchymal stem cells
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 |
|---|---|---|
| Stem cell & quanitative computed tomography QCT testing | The association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery and mesechymal stem cell assays, obtained at time of surgery, will evaluate if stem cells can predict orthopaedic surgical outcomes. Detailed Description: Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can Stem Cells Predict Orthopaedic Outcomes?
Bone mineral density adjacent to acetabular implants will be evaluated using QCT which can show early bony changes, which can provide information about the quality of implant fixation and surrounding bone adaption. X-rays will evaluate component loosening, wear, alignmet and osteolytis. Patient characteristics will be summarized using descriptive statistics. Spearman correlation coefficients will be used to assess the association of Mesenchymal stem cell assays and bone density findings.
Measured: Enrollment expected to begin June 2011and this pilot study is expected to be completed by May 2012.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study start22 Apr 2011
- Primary completion10 Jan 2014
- Study completion10 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Garvin, MD, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366911
- Sponsor's protocol ID
- 0168-11-FB
- Status last verified
- Sep 2023
- First submitted
- 4 May 2011
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Stem Cells Predict Orthopaedic Outcomes? The Correlation of Bone Density Findings Post Total Hip Arthoplasty With Stem Cell Assays Obtaned at Time of Surgery
- ClinicalTrials.gov ID
- NCT01366911
- Acronym / sponsor ID
- 0168-11-FB
- Conditions
- Hip Arthroplasty
- Keywords
- stem cells, QCT testing, Bone density findings, mesenchymal stem cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 22 Apr 2011 (actual)
- Primary completion
- 10 Jan 2014 (actual)
- Study completion
- 10 Jan 2014 (actual)
- First posted
- 6 Jun 2011 (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 pilot study to provide preliminary data of the association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays, obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic surgical outcomes.
Detailed description
Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs.
This ability to identify older individuals with compromised stem cell function could offer opportunities to develop and test new preventative and therapeutic strategies to improve outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell & quanitative computed tomography QCT testing | – | –The association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery and mesechymal stem cell assays, obtained at time of surgery, will evaluate if stem cells can predict orthopaedic surgical outcomes. Detailed Description: Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopaedic surgical patients at specific clinic
Key inclusion criteria (1 listed)
- subjects who previously had a total hip arthroplasty and had stem cell assays completed on excess bone marrow
Key exclusion criteria (1 listed)
- Subjects who do not wish to participate.
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
Can Stem Cells Predict Orthopaedic Outcomes?
Time frame: Enrollment expected to begin June 2011and this pilot study is expected to be completed by May 2012.
Bone mineral density adjacent to acetabular implants will be evaluated using QCT which can show early bony changes, which can provide information about the quality of implant fixation and surrounding bone adaption. X-rays will evaluate component loosening, wear, alignmet and osteolytis. Patient characteristics will be summarized using descriptive statistics. Spearman correlation coefficients will be used to assess the association of Mesenchymal stem cell assays and bone density findings.
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 6 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.
Kevin Garvin, MD principal investigator
UNMC
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 Hip Arthroplasty, 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 6 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?
Can Stem Cells Predict Orthopaedic Outcomes? (time frame: Enrollment expected to begin June 2011and this pilot study is expected to be completed by May 2012.). 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 6 Sep 2023.