Clinical trial NCT00632294: Retrospective Study of the Biomechanical Properties of Large Allografts
Official title: Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Cancer
Keywords: Bone Cancer
Allograft Retrieval
Allograft Bone
Bone Mineral Density
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Musculoskeletal Transplant Foundation
First posted: 2008-03-10
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that require the retrieval of a bone allograft (transplant).

Brief summary: Primary Objectives:

1. 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.
2. To correlate physical properties to patient demographics and medical treatment received.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients that require retrieval of a previously implanted large allograft.

Exclusion Criteria:

* None

Primary outcomes:
measure: 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.
timeFrame: 3 Years
Secondary outcomes:
measure: 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.
timeFrame: 3 Years
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Valerae O. Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: