Purpose

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


Condition Intervention Phase
Bone Cancer
Procedure: retrieve massive allograft
Phase IV

Genetics Home Reference related topics:   Bone Cancer  

MedlinePlus related topics:   Bone Cancer   Cancer  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Physical Characteristics of Retrieved Massive Allografts

Further study details as provided by University of Florida:

Estimated Enrollment:   30
Study Start Date:   December 1999

Detailed Description:

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, histomophometric 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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160758

Contacts
Contact: Mark T. Scarborough, M.D.     352-273-7002     scarbmt@ortho.ufl.edu    

Locations
United States, Florida
UF Orthopaedics and Sports Medicine Institute     Recruiting
      Gainesville, Florida, United States, 32611
      Contact: Darlene E. Bailey     352-273-7073     bailede@ortho.ufl.edu    
      Principal Investigator: Mark T. Scarborough, M.D.            

Sponsors and Collaborators
University of Florida

Investigators
Principal Investigator:     Mark T. Scarborough, M.D.     University of Florida    
Contact: Mark T. Scarborough, M.D.     352-273-7002     scarbmt@ortho.ufl.edu    
United States, Florida
UF Orthopaedics and Sports Medicine Institute     Recruiting
      Gainesville, Florida, United States, 32611
      Contact: Darlene E. Bailey     352-273-7073     bailede@ortho.ufl.edu    
      Principal Investigator: Mark T. Scarborough, M.D.            
University of Florida
Principal Investigator:     Mark T. Scarborough, M.D.     University of Florida    
  More Information

Study ID Numbers:   214-1999
First Received:   September 8, 2005
Last Updated:   May 9, 2008
ClinicalTrials.gov Identifier:   NCT00160758
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Bone Neoplasms
Bone neoplasms
Bone Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Bone Neoplasms

Source: National Library of Medicine (NLM) June 30, 2008