Retrospective Study of the Biomechanical Properties of Large Allografts - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Musculoskeletal Transplant Foundation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00632294

Purpose

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.

Condition	Intervention
Bone Cancer	Procedure: Tissue Sample

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Retrieved Allograft Study: Retrospective Study of the Biomechanical Properties of Large Allografts

Resource links provided by NLM:

MedlinePlus related topics: Bone Cancer Cancer Minerals

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen 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.

Estimated Enrollment:	200
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632294

Contacts

Contact: Susan Banner, BS

713-745-4117

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Valerae O. Lewis, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Musculoskeletal Transplant Foundation

Investigators

Principal Investigator:

Valerae O. Lewis, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Valerae O. Lewis, MD/Associate Professor )
Study ID Numbers:	2007-0689
Study First Received:	February 4, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00632294 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Bone Cancer
Allograft Retrieval
Allograft Bone
Bone Mineral Density

Study placed in the following topic categories:

Musculoskeletal Diseases
Bone Neoplasms
Bone Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Bone Neoplasms
Bone Diseases

ClinicalTrials.gov processed this record on September 10, 2009