Stem Cells Predicting Orthopedic Outcomes

NCT01366911 | Completed

• 1 other identifier: 0168-11-FB
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

Brief 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 to evaluate if stem cells can predict orthopaedic surgical outcomes.

Conditions

Hip Arthroplasty

Keywords

stem cells; QCT testing; Bone density findings; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment expected to begin June 2011and this pilot study is expected to be completed by May 2012.

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic surgical patients at specific clinic

You may qualify if:

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

You may not qualify if:

• Subjects who do not wish to participate.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Orthopaedic Surgery

Omaha, Nebraska, 68198, United States

Location

Study Officials

• Kevin Garvin, MD

  UNMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: June 6, 2011
• Study Start: April 22, 2011
• Primary Completion: January 10, 2014
• Study Completion: January 10, 2014
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

US (1)