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Physical Characteristics of Retrieved Massive Allografts

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ClinicalTrials.gov Identifier: NCT00160758
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment
Bone Cancer Procedure: retrieve massive allograft

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.

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physical Characteristics of Retrieved Massive Allografts
Study Start Date : December 1999
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: retrieve massive allograft
    Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160758


Locations
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United States, Florida
UF Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Mark T. Scarborough, M.D. University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00160758    
Other Study ID Numbers: 214-1999
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases