HLA Sensitization Following Major Cortical Allograft Bone Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Bone Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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retrieve blood samples

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark T. Scarborough, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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173-2005

Identifier Type: -

Identifier Source: org_study_id