Retrospective Study of the Biomechanical Properties of Large Allografts

July 31, 2012 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that require the retrieval of a bone allograft (transplant).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Musculoskeletal Transplant Foundation

Investigators

  • Principal Investigator: Valerae O. Lewis, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0689

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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