Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00160758
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Characteristics of Retrieved Massive Allografts
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Physical Characteristics of Retrieved Massive Allografts
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: