Stem Cells Predicting Orthopedic Outcomes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01366911
First received: May 4, 2011
Last updated: June 3, 2011
Last verified: June 2011
  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: 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

Resource links provided by NLM:


Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kevin Garvin, MD, UNMC Dept of Orthopaedic Surgery
ClinicalTrials.gov Identifier: NCT01366911     History of Changes
Other Study ID Numbers: 168-11-FB
Study First Received: May 4, 2011
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
stem cells
QCT testing
Bone density findings
mesenchymal stem cells

ClinicalTrials.gov processed this record on October 22, 2014