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Physical Characteristics of Retrieved Massive Allografts
This study is currently recruiting participants.
Study NCT00160758   Information provided by University of Florida
First Received: September 8, 2005   Last Updated: May 13, 2009   History of Changes

September 8, 2005
May 13, 2009
December 1999
 
 
 
Complete list of historical versions of study NCT00160758 on ClinicalTrials.gov Archive Site
 
 
 
Physical Characteristics of Retrieved Massive Allografts
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.

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.

Phase IV
Observational
Case-Only, Prospective
Bone Cancer
Procedure: retrieve massive allograft
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
 
 

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Both
 
No
Contact: Mark T. Scarborough, M.D. 352-273-7002 scarbmt@ortho.ufl.edu
United States
 
NCT00160758
Mark Scarborough, MD, Professor, Department of Orthopaedics and Rehabilitation, University of Florida
214-1999
University of Florida
 
Principal Investigator: Mark T. Scarborough, M.D. University of Florida
University of Florida
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP