Stem Cells Predicting Orthopedic Outcomes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01366911

Enrollment

203

Registered

2011-06-06

Start date

2011-04-22

Completion date

2014-01-10

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthroplasty

Keywords

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results