Retrospective Study of the Biomechanical Properties of Large Allografts

Study Overview
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Brief Summary
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Primary Objectives: 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.

Detailed Description
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Allograft Surgery: 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. Tissue Research: 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. Data Collection: 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.

Official Title
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Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts

Conditions
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Bone Cancer

Intervention / Treatment
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* Procedure: Tissue Sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that require retrieval of a previously implanted large allograft. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrieved Allograft<br>Patients that require the retrieval of a bone allograft (transplant). | Procedure: Tissue Sample<br>* A leftover sample of the removed allograft bone will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Cancer, Allograft Retrieval, Allograft Bone, Bone Mineral Density