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


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Bone Cancer

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome 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.

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Valerae O. Lewis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0689

NCT ID:

NCT00632294

Start Date:

December 2007

Completion Date:

September 2009

Related Keywords:

  • Bone Cancer
  • Bone Cancer
  • Allograft Retrieval
  • Allograft Bone
  • Bone Mineral Density
  • Bone Neoplasms
  • Osteosarcoma

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030