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HLA Sensitization Following Major Cortical Allograft Bone Procedures

Phase 4
12 Years
80 Years
Not Enrolling
Bone Cancer

Thank you

Trial Information

HLA Sensitization Following Major Cortical Allograft Bone Procedures

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

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

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Mark T. Scarborough, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida


United States: Institutional Review Board

Study ID:




Start Date:

September 1999

Completion Date:

March 2010

Related Keywords:

  • Bone Cancer
  • Bone Neoplasms
  • Osteosarcoma



UF Orthopaedics and Sports Medicine Institute Gainesville, Florida  32611