Bone CancerNCT00160758
Physical Characteristics of Retrieved Massive Allografts
An observational study of Bone Cancer, run by University of Florida at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Cancer
- What is being tested?
- retrieve massive allograft
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthopaedic clinic
Who may be able to join
- failed allograft bone
- removal of allograft due to oncological complications
- amputation due to oncological complications
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32611
About this study
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.
- Conditions
- Bone Cancer
- Being tested
- retrieve massive allograft
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrieve massive allograftProcedure or surgery
Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 1999
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark T. Scarborough, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160758
- Sponsor's protocol ID
- 214-1999
- Status last verified
- Oct 2012
- First submitted
- 8 Sep 2005
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Characteristics of Retrieved Massive Allografts
- ClinicalTrials.gov ID
- NCT00160758
- Acronym / sponsor ID
- 214-1999
- Conditions
- Bone Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopaedic clinic
Key inclusion criteria (3 listed)
- failed allograft bone
- removal of allograft due to oncological complications
- amputation due to oncological complications
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrieve massive allograftAllograft constructs removed because of infection or cancer complications will be retained for biomechanical testing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark T. Scarborough, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.