Stem Cells Predicting Orthopedic Outcomes

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.

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Key information

Conditions

Hip Arthroplasty

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center, Orthopaedic Surgery

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jun 6, 2011
Registry last updated: Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed