Retrospective Study of the Biomechanical Properties of Large Allografts

NCT00632294 | Terminated

• 1 other identifier: 2007-0689
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 2.To correlate physical properties to patient demographics and medical treatment received.

Conditions

Bone Cancer

Keywords

Bone Cancer; Allograft Retrieval; Allograft Bone; Bone Mineral Density

Outcome Measures

Primary Outcomes (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.

  3 Years

Secondary Outcomes (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.

  3 Years

Study Arms (1)

Retrieved Allograft

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

Procedure: Tissue Sample

Interventions

Tissue Sample PROCEDURE

A leftover sample of the removed allograft bone will be collected.

Retrieved Allograft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

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.

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Valerae O. Lewis, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: March 10, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)