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Retrospective Study of the Biomechanical Properties of Large Allografts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00632294
Recruitment Status : Terminated (Low accrual.)
First Posted : March 10, 2008
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Bone Cancer Procedure: Tissue Sample

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.

Study Design
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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts
Study Start Date : December 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Retrieved Allograft
Patients that require the retrieval of a bone allograft (transplant).
 Procedure: Tissue Sample
A leftover sample of the removed allograft bone will be collected.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that require the retrieval of a bone allograft (transplant).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632294


Locations
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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Musculoskeletal Transplant Foundation
Investigators
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Principal Investigator: Valerae O. Lewis, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00632294    
Other Study ID Numbers: 2007-0689
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Bone Cancer
Allograft Retrieval
Allograft Bone
Bone Mineral Density
Additional relevant MeSH terms:
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Bone Neoplasms
Osteosarcoma
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
 Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma