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Retrospective Study of the Biomechanical Properties of Large Allografts

This study has been terminated.
(Low accrual.)
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00632294
First received: February 4, 2008
Last updated: July 31, 2012
Last verified: July 2012
History of Changes

February 4, 2008
July 31, 2012
December 2007
September 2009   (final data collection date for primary 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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
The goal of this clinical research study is to learn about the properties (such as bone strength, bone density, and new bone formation) of the removed transplant tissue and how it integrated with your own tissues during the time it was implanted in you. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00632294 on ClinicalTrials.gov Archive Site
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 ]
Additional information such as the reasons this allograft was used and the length of time before it was removed will also be compared to other patients who have received similar allograft tissues that were removed. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Retrospective Study of the Biomechanical Properties of Large Allografts
Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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.
Non-Probability Sample

Patients that require the retrieval of a bone allograft (transplant).
Bone Cancer
Procedure: Tissue Sample
A leftover sample of the removed allograft bone will be collected.
Retrieved Allograft
Patients that require the retrieval of a bone allograft (transplant).
Intervention: Procedure: Tissue Sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00632294
2007-0689
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Musculoskeletal Transplant Foundation
Principal Investigator: Valerae O. Lewis, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP