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HLA Sensitization Following Major Cortical Allograft Bone Procedures

HLA Sensitization Following Major Cortical Allograft Bone Procedures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00160719
Enrollment
10
Registered
2005-09-12
Start date
1999-09-30
Completion date
2010-03-31
Last updated
2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Cancer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREretrieve blood samples

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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026