Stem Cells Predicting Orthopedic Outcomes

Hip Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366911
• Other study ID #: 0168-11-FB
• Status: Completed
• Start date: April 22, 2011
• Est. completion date: January 10, 2014

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 10, 2014
• Est. primary completion date: January 10, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthroplasty

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Orthopaedic Surgery	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.