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Physical Characteristics of Retrieved Massive Allografts


Phase 4
N/A
N/A
Not Enrolling
Both
Bone Cancer

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Trial Information

Physical Characteristics of Retrieved Massive Allografts


Allograft bone is the primary source of graft material for large skeletal defects resulting
from trauma, disease, oncological resection, or reconstruction of failed total joint
arthroplasties. The physical characteristics of such grafts after various intervals of
remodeling and incorporation in vivo have never been studied.

The purpose of this study is to obtain tissue from allografts retrieved at autopsy, at
amputation for oncological complications and from patients undergoing revision procedures
for failed allograft transplantation. We will evaluate the mechanical properties,
histomorphometric indices and presence of microfractures.

Our hypotheses are:

- histomorphometric parameters of porosity and microfracture density will predict
allograft strength,

- microfracture density will be correlated with time in vivo and allograft strength,

- the rate of host-allograft nonunion and fracture will correlate with radiation therapy
and chemotherapy.

The retrieved tissue will be processed using standard undecalcified histology and
quantitatively assessed for degree of incorporation, allograft porosity, and microfracture
density. The biomechanical characteristics of the bulk allograft and allograft-host
junction will be quantified and compared to allograft bone prior to transplantation.


Inclusion Criteria:



- failed allograft bone

- removal of allograft due to oncological complications

- amputation due to oncological complications

Exclusion Criteria:

- none

Type of Study:

Observational

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

Authority:

United States: Institutional Review Board

Study ID:

214-1999

NCT ID:

NCT00160758

Start Date:

December 1999

Completion Date:

September 2009

Related Keywords:

  • Bone Cancer
  • Bone Neoplasms
  • Osteosarcoma

Name

Location

UF Orthopaedics and Sports Medicine InstituteGainesville, Florida  32611