Stem Cells Predicting Orthopedic Outcomes

Completed

• Conditions: Hip Arthroplasty

• Registration Number: NCT01366911
• Lead Sponsor: University of Nebraska

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.

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 Timeline

• Study Start: 2011-04-22
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Primary Completion: 2014-01-10
• Study Completion: 2014-01-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Can Stem Cells Predict Orthopaedic Outcomes?	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.

Trial Locations

Locations (1)

University of Nebraska Medical Center, Orthopaedic Surgery; 🇺🇸 Omaha, Nebraska, United States