Retrospective Study of the Biomechanical Properties of Large Allografts

Bone Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00632294
• Other study ID #: 2007-0689
• Status: Terminated
• Phase: N/A
• First received: February 4, 2008
• Last updated: July 31, 2012
• Start date: December 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bone Cancer
• Bone Neoplasms
• Osteosarcoma

Intervention

Procedure:
• Tissue Sample
A leftover sample of the removed allograft bone will be collected.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 Years	No
Secondary	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.		3 Years	No

External Links

•   MD Anderson Cancer Center