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Physical Characteristics of Retrieved Massive Allografts

Physical Characteristics of Retrieved Massive Allografts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00160758
Enrollment
18
Registered
2005-09-12
Start date
1999-12-31
Completion date
2009-09-30
Last updated
2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Cancer

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.

Interventions

PROCEDUREretrieve massive allograft

Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026