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CompletedNCT00160758Updated Oct 30, 2012

Physical Characteristics of Retrieved Massive Allografts

An observational study in Bone Cancer, sponsored by University of Florida. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-10-30.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
18
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Bone Cancer

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03

In context

Bone Neoplasms

322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's enrollment of 18 is below the median of 75 across 93 observational studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Orthopaedic clinic

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
18 participants (actual)

Interventions

  • Procedureretrieve massive allograft

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

06

Study locations

1 site
  • UF Orthopaedics and Sports Medicine Institute
    Gainesville, Florida 32611, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00160758
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Dec 1999
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Oct 30, 2012

Study contacts

Mark T. Scarborough, M.D.
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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