Retrospective Study of the Biomechanical Properties of Large Allografts
- To evaluate the material properties, histomorphometric indices, bone mineral density (BMD), and presence of microfractures in retrieved large allograft cortical bone specimens removed from orthopaedic oncology patients.
- To correlate physical properties to patient demographics and medical treatment received.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts|
- To learn about properties (such as bone strength, bone density, and new bone formation) of removed transplant tissue and how it integrated with participant's own tissues during the time it was implanted. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
- To compare information such as the reasons this allograft was used and the length of time before it was removed to other patients who have received similar allograft tissues that were removed. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
A leftover sample of the removed allograft bone will be collected and used to learn about the properties (such as bone strength, bone density, and new bone formation) of the removed transplant tissue.
|Study Start Date:||December 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Patients that require the retrieval of a bone allograft (transplant).
Procedure: Tissue Sample
A leftover sample of the removed allograft bone will be collected.
As a standard of care, you will be having surgery to remove allograft tissue that has failed or because there were other complications following your earlier transplant. You will be separately consented for this surgery, which will describe the procedure and its risks in detail.
If you agree to take part in this study, leftover sample of the removed allograft bone will be collected and used to learn about the properties (such as bone strength, bone density, and new bone formation) of the removed transplant tissue. This tissue will be stored at the University of Arkansas for use in this study. Any remaining leftover tissue will be destroyed by the end of December 2011.
Before you have surgery, you will have an x-ray. This is also part of standard of care. If you take part in this study, this x-ray will be used to learn about the properties of the transplant tissue.
All other information will be coming from your medical record, either from your past visits or as a result of your surgery. The information being collected will include information about your graft during the time it was within your body and observations made by your surgeon at its removal.
Length of Study:
Your participation in this study will be over after your tissue and data are collected.
This is an investigational study. Up to 200 patients will be enrolled on this multicenter study. Up to 20 will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632294
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Valerae O. Lewis, MD||M.D. Anderson Cancer Center|