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OpenTrials
Completed

NCT Number: NCT00160719

HLA Sensitization Following Major Cortical Allograft Bone Procedures

The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.

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Key information

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

About this study

Patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). However, sometimes this replacement bone does not heal together with the patient's bone. The reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. You have been asked to participate in this study because you are scheduled to undergo this type of surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces.

Exclusion criteria

  • Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study.

Treatment and study plan

retrieve blood samples

Procedure

blood samples obtain pre-op, 6 and 12 months post-op

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
1999
Primary completion
2010
Study completion
2010
First posted
Sep 12, 2005
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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