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| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 1999 |
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:
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 |
Orthopaedic clinic
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark T. Scarborough, M.D. | 352-273-7002 | scarbmt@ortho.ufl.edu |
| United States, Florida | |
| UF Orthopaedics and Sports Medicine Institute | Recruiting |
| Gainesville, Florida, United States, 32611 | |
| Contact: Mieko M Dunn, MHA 352-273-7418 dunnmm@ortho.ufl.edu | |
| Principal Investigator: Mark T. Scarborough, M.D. | |
| Principal Investigator: | Mark T. Scarborough, M.D. | University of Florida |
More Information
| 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: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00160758 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neoplasms Neoplasms by Site Musculoskeletal Diseases Bone Neoplasms Bone Diseases |