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Stem Cells Predicting Orthopedic Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366911
First Posted: June 6, 2011
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kevin Garvin, MD, University of Nebraska
  Purpose
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.

Condition
Hip Arthroplasty

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
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

Further study details as provided by Kevin Garvin, MD, University of Nebraska:

Primary Outcome Measures:
  • 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.


Enrollment: 203
Study Start Date: April 2011
Study Completion Date: January 10, 2014
Primary Completion Date: January 10, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
stem cell QCT testing

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Orthopaedic surgical patients at specific clinic
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366911


Locations
United States, Nebraska
Dept of Orthopaedic Surgery at University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Dept. of Orthopaedic Surgery
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Kevin Garvin, MD UNMC
  More Information

Responsible Party: Kevin Garvin, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01366911     History of Changes
Other Study ID Numbers: 168-11-FB
First Submitted: May 4, 2011
First Posted: June 6, 2011
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Kevin Garvin, MD, University of Nebraska:
stem cells
QCT testing
Bone density findings
mesenchymal stem cells