Physical Characteristics of Retrieved Massive Allografts

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

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-12-31

Study Completion Date

2009-09-30

Brief Summary

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This purpose of this study is to measure the strength of tissue allografts that have been in the body various lengths of time.

Detailed Description

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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.

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 massive allograft

Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* failed allograft bone
* removal of allograft due to oncological complications
* amputation due to oncological complications

Exclusion Criteria

* none

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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214-1999

Identifier Type: -

Identifier Source: org_study_id