Stem Cells Predicting Orthopedic Outcomes

NCT ID: NCT01366911

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-22

Study Completion Date

2014-01-10

Brief Summary

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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

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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

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Hip Arthroplasty

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* subjects who previously had a total hip arthroplasty and had stem cell assays completed on excess bone marrow

Exclusion Criteria

* Subjects who do not wish to participate.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Garvin, MD

Role: PRINCIPAL_INVESTIGATOR

UNMC

Locations

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University of Nebraska Medical Center, Orthopaedic Surgery

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0168-11-FB

Identifier Type: -

Identifier Source: org_study_id

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