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Physical Characteristics of Retrieved Massive Allografts
This study has been completed.
First Received: September 8, 2005   Last Updated: January 19, 2010   History of Changes
Sponsor: 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

Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Physical Characteristics of Retrieved Massive Allografts

Resource links provided by NLM:


Further study details as provided by University of Florida:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: December 1999
Study Completion Date: September 2009
Intervention Details:
    Procedure: retrieve massive allograft
    Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing
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, 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Orthopaedic clinic

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

Locations
United States, Florida
UF Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Mark T. Scarborough, M.D. University of Florida
  More Information

No publications provided

Responsible Party: Department of Orthopaedics and Rehabilitation, University of Florida ( Mark Scarborough, MD, Professor )
Study ID Numbers: 214-1999
Study First Received: September 8, 2005
Last Updated: January 19, 2010
ClinicalTrials.gov Identifier: NCT00160758     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 08, 2010