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Physical Characteristics of Retrieved Massive Allografts
This study is currently recruiting participants.
Verified by University of Florida, May 2008
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00160758
  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

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
  More Information

Study ID Numbers: 214-1999
Study 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:
Musculoskeletal Diseases
Bone Neoplasms
Bone neoplasms
Bone Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009