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OpenTrials
Completed

NCT Number: NCT00160758

Physical Characteristics of Retrieved Massive Allografts

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

retrieve massive allograft

Procedure

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
1999
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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