NCT00160719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

10.5 years

First QC Date

September 8, 2005

Last Update Submit

October 26, 2012

Conditions

Bone Cancer

Interventions

retrieve blood samplesPROCEDURE

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

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Orthopaedic clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Mark T. Scarborough, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 1999

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

US(1)